Instrument, Manual, Surgical, General Use

FDA product code MDM · 44 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4800
Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-06-09 – 2008-08-08

MDM 2008-08-08

FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

Applicant Injectimed, Inc.

K number K073664

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MDM 2005-08-15

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM

Applicant Futumeds Sdn Bhd

K number K050575

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MDM 2005-05-18

EUTROCHAR

Applicant Special Devices, Inc.

K number K050957

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MDM 2002-12-18

ANDREWS INTRODUCER, MODEL ASI01

Applicant Andrews Surgical Innovations, Ltd.

K number K023173

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MDM 2002-11-13

MICROVASIVE PULMONARY GUIDEWIRE

Applicant Boston Scientific Corp

K number K022059

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MDM 2001-12-07

LIGHT SABER INTRODUCER NEEDLE

Applicant Minrad, Inc.

K number K013040

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MDM 2001-06-22

CHESS HAND SURGERY SYSTEM

Applicant Canica Design, Inc.

K number K010184

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MDM 1999-03-30

SAPHLIFT

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K990062

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MDM 1998-07-09

ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG

Applicant ETHICON, Inc.

K number K981579

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MDM 1995-03-01

TUNNELER

Applicant Denver Biomedicals, Inc.

K number K943968

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MDM 1994-11-28

DERMAVBLADE(TM)

Applicant Hasting'S Biomedical Corp.

K number K945430

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MDM 1994-11-09

EAST WEST INSTRUMENTS

Applicant East West Instruments, Inc.

K number K941193

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MDM 1994-08-26

APEX DISPOSABLE INSTRUMENTS

Applicant Apex Ent., Inc.

K number K941907

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MDM 1994-08-25

DEEP SUTURE

Applicant Automated Medical Products Corp.

K number K942818

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MDM 1994-07-19

CLAMPS AND CLIPS

Applicant Surgin Surgical Instrumentation, Inc.

K number K942896

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MDM 1994-03-14

SURGICAL INSTRUMENT, DISPOSABLE

Applicant Her-Mar, Inc.

K number K940684

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MDM 1994-03-07

ACU-DISPO-CE(TM)

Applicant Acuderm, Inc.

K number K933265

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MDM 1993-12-01

ACU-HEMOSTATIC RING

Applicant Acuderm, Inc.

K number K933866

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MDM 1993-11-08

DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH

Applicant Dermatopathology Laboratory

K number K925653

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MDM 1993-05-24

HOSPITAL KIT DK 117

Applicant Savoy Medical Supply Co., Inc.

K number K922130

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MDM 1993-05-19

SUTUREMATE

Applicant Surgical Safety Products, Inc.

K number K926126

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MDM 1993-04-23

DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC

Applicant Falcon Instruments, Inc.

K number K930775

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MDM 1993-03-29

HOSPITAL KIT GP 103

Applicant Savoy Medical Supply Co., Inc.

K number K922127

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MDM 1993-03-26

SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT

Applicant Savoy Medical Supply Co., Inc.

K number K923281

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MDM 1993-03-23

HOSPITAL KIT EP 104

Applicant Savoy Medical Supply Co., Inc.

K number K922128

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MDM 1993-03-16

BREAST STABILIZER

Applicant Bip USA, Inc.

K number K925874

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MDM 1993-02-17

ORC ENDOSCOPIC INSTRUMENT HOLDER

Applicant O.R. Concepts, Inc.

K number K930399

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MDM 1993-02-05

AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS

Applicant American Biomaterials Corp.

K number K924725

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MDM 1993-02-05

PERSONNA SAFETY SCALPEL

Applicant American Safety Razor Co.

K number K924503

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MDM 1992-12-17

CENTURION DISPOSABLE INSTRUMENTS

Applicant Tri-State Hospital Supply Corp.

K number K923812

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MDM 1992-12-03

DISPOSABLE CURETTE

Applicant Dermtec, Inc.

K number K921022

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MDM 1992-11-19

LACERATION REPAIR TRAY

Applicant Cypress Medical Products, Ltd.

K number K921988

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MDM 1992-10-28

FRAY BIO-PUNCH

Applicant Fray Products Corp.

K number K921822

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MDM 1992-09-11

DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE

Applicant Supra Instruments, Inc.

K number K922874

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MDM 1992-09-11

DISPOSABLE SCISSORS

Applicant Falcon Instruments, Inc.

K number K920297

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MDM 1992-09-11

DISPOSABLE FORCEPS

Applicant Falcon Instruments, Inc.

K number K920296

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MDM 1992-04-29

SURGICAL INSTRUMENT STAND

Applicant Murphy Medical Center

K number K921210

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MDM 1991-05-13

QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER

Applicant Deroyal Industries, Inc.

K number K911369

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MDM 1991-05-08

QUALTEX SUTURE BOOTIES

Applicant Deroyal Industries, Inc.

K number K911895

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MDM 1991-01-31

JAIN SUTURE/VESIBAND ORGANIZER

Applicant Jain Surgical Equipment, Inc.

K number K905105

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MDM 1990-12-19

YANKAUER SUCTION DEVICE

Applicant Medovations, Inc.

K number K905478

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MDM 1986-01-24

SHAVE PREP TRAY

Applicant Dynarex Corp.

K number K855132

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MDM 1981-11-16

SILICONE IMPLANTS

Applicant Sutter Biomedical, Inc.

K number K812691

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MDM 1980-06-09

THE EQUALIZER

Applicant The Anspach Effort, Inc.

K number K801328

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