Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Instrument, Biopsy

FDA product code KNW · 347 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1075
Review panel: SU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-01 – 2026-08-28

KNW 1999-03-30

DAUM NEUROCUT NEUROBIOPSYNEEDLE

Applicant Daum Corp.

K number K990278

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KNW 1998-12-10

MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE

Applicant Medsol Corp.

K number K983187

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KNW 1998-09-23

MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT

Applicant Medical Device Technologies, Inc.

K number K982960

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KNW 1998-09-09

LIGHT SABER BONE BIOPSY NEEDLE

Applicant Minrad, Inc.

K number K982735

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KNW 1998-09-08

PROSTATE BIOPSY NEEDLE

Applicant Remington Medical, Inc.

K number K982401

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KNW 1998-08-05

LIGHT SABER CORE TISSUE NEEDLE

Applicant Minrad, Inc.

K number K981796

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KNW 1998-07-28

C0-AXIAL INTRODUCER NEEDLE

Applicant Inrad

K number K981721

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KNW 1998-07-17

MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT

Applicant Medical Device Technologies, Inc.

K number K982085

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KNW 1998-07-08

SPEED-CUT AUTOMATIC BIOPSY SYSTEM

Applicant Gallini U.S., LLC

K number K981301

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KNW 1998-07-07

PERCUTANEOUS BREAST BIOPSY (PBB)

Applicant Urothealth System, Inc.

K number K972328

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KNW 1998-06-29

DAUM BONE BIOPSY SET

Applicant Daum Corp.

K number K981320

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KNW 1998-06-22

ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

Applicant Inrad

K number K981166

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KNW 1998-06-10

MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE

Applicant Medical Biopsy, Inc.

K number K981477

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KNW 1998-05-21

SPIGAL NEEDLE

Applicant Gallini U.S., LLC

K number K980676

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KNW 1998-05-06

QUICK-CUT AUTOMATIC BIOPSY SYSTEM

Applicant Gallini U.S., LLC

K number K980479

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KNW 1998-03-19

PUNCTURENEEDLE

Applicant Ferguson Medical

K number K963794

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KNW 1998-03-09

DAUM NEUROBIOPSY NEEDLE

Applicant Daum Corp.

K number K974631

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KNW 1998-03-06

DAUM BIOPSYGUN

Applicant Daum Corp.

K number K974576

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KNW 1998-03-06

DAUM ASPIRATIONBIOPSY NEEDLE

Applicant Daum Corp.

K number K974575

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KNW 1998-03-06

DAUM NEUROPUNCTURE NEEDLE

Applicant Daum Corp.

K number K974574

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KNW 1998-02-18

MANAN LIVER BIOPSY KIT

Applicant Medical Device Technologies, Inc.

K number K980452

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KNW 1998-02-18

ACRI R NEEDLE

Applicant Gallini U.S., LLC

K number K980248

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KNW 1998-02-18

MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM

Applicant Medical Device Technologies, Inc.

K number K980226

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KNW 1998-02-06

MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

Applicant Manan Medical Products, Inc.

K number K980211

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KNW 1998-02-03

MD TECH BIOPSY SET FOR BONE AND BONE MARROW

Applicant Medical Device Technologies, Inc.

K number K980196

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KNW 1998-01-30

MANAN SOFT TISSUE BIOPSY NEEDLES

Applicant Medical Device Technologies, Inc.

K number K980122

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KNW 1998-01-30

IBI

Applicant Gallini U.S., LLC

K number K974440

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KNW 1998-01-23

WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE

Applicant Worldwide Medical Technologies, LLC

K number K980068

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KNW 1998-01-23

WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE

Applicant Worldwide Medical Technologies, LLC

K number K974794

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KNW 1998-01-21

REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR

Applicant Telemed Systems, Inc.

K number K974312

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KNW 1998-01-09

MANAN GENERAL PURPOSE INTRODUCER NEEDLE

Applicant Medical Device Technologies, Inc.

K number K980004

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KNW 1998-01-09

MANAN(TM) SUPER-CORE BIOPSY NEEDLES

Applicant Medical Device Technologies, Inc.

K number K974814

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KNW 1998-01-09

GALLINI ABS DEVICE

Applicant Gallini U.S., LLC

K number K973152

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KNW 1998-01-08

MANAN TECHNA-CUT ASPIRATION NEEDLE

Applicant Medical Device Technologies, Inc.

K number K974766

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KNW 1998-01-08

MANAN AUTOMATIC CUTTING NEEDLE

Applicant Manan Medical Products, Inc.

K number K974446

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KNW 1997-12-09

ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY

Applicant Ortho Development Corp.

K number K974158

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KNW 1997-12-09

PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER

Applicant Tao & Tao Technologyt, Inc.

K number K972496

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KNW 1997-12-01

THE AUTO SUTURE* MIBB** SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K973496

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KNW 1997-11-06

STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM

Applicant Laurus Medical Corp.

K number K973215

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KNW 1997-11-03

QUICK-CARE BIOPSY NEEDLE

Applicant Cook, Inc.

K number K973565

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KNW 1997-10-09

MRI COMPATIBLE BIOPSY NEEDLES

Applicant Manan Medical Products, Inc.

K number K962977

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KNW 1997-07-29

GALLINI COAXIAL INTRODUCER

Applicant Gallini U.S., LLC

K number K972266

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KNW 1997-05-21

PAN (CHIBA ASPIRATING NEEDLE)

Applicant Gallini Intl., Inc.

K number K970872

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KNW 1997-05-21

TR NEEDLE

Applicant Gallini Intl., Inc.

K number K970871

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KNW 1997-03-28

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)

Applicant Biopsys Medical, Inc.

K number K970565

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KNW 1997-03-20

SURE CORE BIOPSY KIT

Applicant Interventional Concepts, Inc.

K number K963813

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KNW 1997-01-03

TZ

Applicant Gallini Intl., Inc.

K number K964777

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KNW 1996-12-20

AUTO SUTURE* ABBI* SYSTEM

Applicant United States Surgical, A Division of Tyco Healthc

K number K963825

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KNW 1996-12-06

MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA

Applicant Medical Device Technologies, Inc.

K number K962969

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KNW 1996-11-21

SPEED-CUT

Applicant Gallini Intl., Inc.

K number K961407

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KNW 1996-10-23

SKINNY,FRANSEEN,WESCOTT NEEDLES

Applicant Baxter Healthcare Corp

K number K962907

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KNW 1996-10-10

BIOPSY INTRODUCER NEEDLE

Applicant Baxter Healthcare Corp

K number K963390

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KNW 1996-07-30

BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER

Applicant C.R. Bard, Inc.

K number K962077

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KNW 1996-04-05

TEMNO DOUBLE SHOT BIOPSY NEEDLE

Applicant Bauer Medical, Inc.

K number K960065

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KNW 1996-04-05

TEMNO ACHIEVE BIOPSY NEEDLE

Applicant Bauer Medical, Inc.

K number K960064

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KNW 1996-04-04

18 GAUGE TRU-CUT BIOPSY NEEDLE

Applicant Baxter Healthcare Corp

K number K960509

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KNW 1996-04-04

LILY MULTICANNULA GUIDE

Applicant Lily Imaging Solutions Co.

K number K954999

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KNW 1995-12-29

AUTOMATED TRU-CUT BIOPSY DEVICE

Applicant Baxter Healthcare Corp

K number K954529

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KNW 1995-10-30

NEEDLE OR CUTTER

Applicant Biophysic Medical, Inc.

K number K953399

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KNW 1995-09-29

TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE

Applicant Promex, Inc.

K number K954265

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KNW 1995-09-15

BIOACCESS BONE BIOPSY SYSTEM

Applicant Bioaccess, Inc.

K number K954151

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KNW 1995-09-08

URESIL INTRODUCING NEEDLE

Applicant Uresil Corp.

K number K953923

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KNW 1995-09-08

BIOPSY NEEDLE

Applicant Biopsys Medical, Inc.

K number K953880

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KNW 1995-04-06

MODIFIED BIOPSY NEEDLE

Applicant Biopsys Medical, Inc.

K number K951229

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KNW 1995-03-02

MANAN SUPER-CORE BIOPSY NEEDLE

Applicant Manan Medical Products, Inc.

K number K950732

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KNW 1994-12-09

BIOPSY DEVICE ACCESSORY

Applicant Biopsys Medical, Inc.

K number K945573

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KNW 1994-10-14

MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE

Applicant Medical Device Technologies, Inc.

K number K944837

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KNW 1994-09-29

TECHNA-CUT ASPIRATION NEEDLE

Applicant Manan Medical Products, Inc.

K number K943651

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KNW 1994-08-26

LIVER BIOPSY KIT

Applicant Manan Medical Products, Inc.

K number K943650

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KNW 1994-07-29

TRU-CORE NEEDLE SET

Applicant Ideamatrix

K number K943368

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KNW 1994-07-13

QUICK CORE II

Applicant Proact, Ltd.

K number K941256

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KNW 1994-07-12

WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE

Applicant Mill-Rose Laboratory

K number K942630

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KNW 1994-07-07

BIOPSY NEEDLE AND HOUSING

Applicant Biopsys Medical, Inc.

K number K942639

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KNW 1994-04-28

BIP MULTI MODIFICATION

Applicant Bip USA, Inc.

K number K934371

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KNW 1994-04-19

BIOPSY NEEDLE AND HOUSING

Applicant Biopsys Medical, Inc.

K number K941549

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KNW 1994-03-14

MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE

Applicant Boston Scientific Corp

K number K935814

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KNW 1994-02-25

MANAN ADAPTER FOR BARD BIOPTY SYSTEM

Applicant Manan Medical Products, Inc.

K number K940365

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KNW 1993-11-12

MANAN ADAPTER FOR BIP BIOPSY DEVICE

Applicant Manan Medical Products, Inc.

K number K933448

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KNW 1993-06-09

ACECUT SUTOMATIC BIOPSY SYSTEM

Applicant Meadox Surgimed, Inc.

K number K930201

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KNW 1993-04-21

EMS BIOPSY INSTRUMENT

Applicant Engineered Medical Systems

K number K930083

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KNW 1993-04-20

OLYMPUS DISPOSABLE BIOPSY FORCEPS

Applicant Olympus Corp.

K number K930241

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KNW 1993-02-16

BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.

Applicant C.R. Bard, Inc.

K number K922939

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KNW 1992-11-24

BIOPSY FORCEPS

Applicant United States Endoscopy Group, Inc.

K number K924106

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KNW 1992-10-13

GRICE SOFT TISSUE BIOPSY KIT

Applicant Ideal Medical, Inc.

K number K922161

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KNW 1992-09-01

MEADOX SURGIMED BIOPSY GUN III

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K922879

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KNW 1992-02-24

SELECTACUT BIOPSY DEVICE

Applicant Biomni Medical Systems, Inc.

K number K914215

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KNW 1992-02-18

MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE

Applicant Manan Medical Products, Inc.

K number K914874

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KNW 1992-02-07

AUTO-VAC BIOPSY NEEDLE

Applicant Angiomed GmbH & Co. Medizintechnik KG

K number K912892

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KNW 1991-11-05

APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501

Applicant Dlp, Inc.

K number K913098

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KNW 1991-08-16

BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

Applicant C.R. Bard, Inc.

K number K910190

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KNW 1991-06-20

MEADOX(R) SURGIMED(R) BIOPSY GUN II

Applicant Meadox Surgimed, Inc.

K number K911635

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KNW 1991-03-08

CCC CROWN-CORE-CUT-NEEDLE

Applicant Uni-Quatro Industries Canada, Inc.

K number K905557

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KNW 1991-02-11

VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)

Applicant Vibronics

K number K904987

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KNW 1990-11-20

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV

Applicant Leigh Med Tech, Inc.

K number K904658

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KNW 1990-09-06

DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES

Applicant Endo-Scientific, Inc.

K number K902066

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KNW 1990-07-27

T19S BIOPSY NEEDLE

Applicant Ohio Medical Instrument Co., Inc.

K number K902077

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KNW 1990-07-16

MEADOX SURGIMED BIOPSY GUN AND NEEDLE

Applicant Meadox Surgimed, Inc.

K number K902461

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KNW 1990-06-27

MAXX 470 CORE BIOPSY GUN

Applicant Dlp, Inc.

K number K900082

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KNW 1990-06-22

INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN

Applicant The Witmoore Group, Inc.

K number K896933

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KNW 1990-06-11

BIOPSY FORCEPS (NON-RIGID)

Applicant Applied Medical Technologies

K number K901339

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