Needle, Aspiration And Injection, Reusable

FDA product code GDM · 48 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: 1977-12-06 – 2007-09-24

GDM 2007-09-24

MARROWMINER

Applicant Stemcor Systems, Inc.

K number K071732

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GDM 1997-06-03

BIOACCESS MARROW HARVEST SYSTEM

Applicant Bioaccess, Inc.

K number K971114

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GDM 1995-09-22

ILIAC CREST BONE MARROW ASPIRATION NEEDLE

Applicant Baxter Healthcare Corp

K number K953082

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GDM 1995-08-07

BIOACCESS MARROW HARVEST SYSTEM

Applicant Bioaccess, Inc.

K number K953064

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GDM 1994-06-16

ENDO-NEEDLE INSTRUMENT

Applicant Gerard Medical, Inc.

K number K936207

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GDM 1993-07-06

ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

Applicant Symbiosis Corp.

K number K930160

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GDM 1992-12-15

BONE MARROW BIOPSY SYSTEM

Applicant The Straumann Co.

K number K923872

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GDM 1992-02-03

BECTON DICKINSON MODIFIED MENGHINI NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K915572

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GDM 1990-12-12

NA NEEDLES

Applicant Olympus Corp.

K number K904667

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GDM 1990-10-31

ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E

Applicant Downs Surgical , Ltd.

K number K903750

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GDM 1990-10-31

ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U

Applicant Downs Surgical , Ltd.

K number K903749

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GDM 1990-10-31

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V

Applicant Downs Surgical , Ltd.

K number K903748

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GDM 1990-10-31

ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U

Applicant Downs Surgical , Ltd.

K number K903747

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GDM 1990-09-05

MANAN BONE BIOPSY NEEDLE

Applicant Manan Medical Products, Inc.

K number K902177

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GDM 1990-07-10

PLEURA BIOPSY DEVICE

Applicant Mill-Rose Laboratory

K number K901995

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GDM 1989-10-17

DIAMOND BLADE SURGICAL KNIVES

Applicant Magnum Diamond, Inc.

K number K895752

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GDM 1989-10-06

SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE

Applicant Go Medical Industries Pty. , Ltd.

K number K895594

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GDM 1989-10-06

ROCKET BONE MARROW NEEDLE

Applicant A & A Medical, Inc.

K number K895551

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GDM 1989-09-21

ADG BONE BIOPSY SYSTEM

Applicant American Design Group, Inc.

K number K890722

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GDM 1989-04-18

CORE BIOPSY NEEDLE, CATALOG CODE #54006

Applicant Dlp, Inc.

K number K891537

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GDM 1989-03-22

ASPIRATING AND IRRIGATING CYSTS NEEDLES

Applicant Go Medical Industries Pty. , Ltd.

K number K885283

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GDM 1988-12-02

KLEIN NEEDLE

Applicant E.L. Medico Intl., Inc.

K number K881784

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GDM 1988-12-02

KLEIN HANDLE

Applicant E.L. Medico Intl., Inc.

K number K881783

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GDM 1988-10-07

WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE

Applicant E.G. Dick & Assoc.

K number K883876

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GDM 1988-08-11

PLEURAL BIOPSY PUNCH NEEDLE

Applicant E.G. Dick & Assoc.

K number K881624

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GDM 1988-07-29

STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC

Applicant Storz Instrument Co.

K number K882240

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GDM 1988-07-25

E-Z-EM(R) LUFKIN BIOPSY NEEDLES

Applicant E-Z-Em, Inc.

K number K882601

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GDM 1988-07-18

SPINAL NEEDLE

Applicant Karlin Technology, Inc.

K number K882073

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GDM 1988-05-13

BREAST LOCALIZATION NEEDLES

Applicant Hart Enterprises, Inc.

K number K881730

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GDM 1988-03-11

SPINAL NEEDLE

Applicant T. Korossurgical Instruments Corp.

K number K880812

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GDM 1987-12-30

WHOLEY (TM) BIOPSY DEVICE

Applicant Medrad, Inc.

K number K874928

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GDM 1987-10-23

RETROBULBAR NEEDLE

Applicant Healthtek, Inc.

K number K873848

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GDM 1987-03-09

HAWKINS BREAST LOCALIZATION NEEDLE

Applicant N-S Medical Products

K number K870523

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GDM 1986-11-17

GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN

Applicant Gaw, Inc.

K number K864193

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GDM 1986-09-29

ANGIOMED VAC-U-CUT BIOPSY NEEDLE

Applicant Angiomed U.S., Inc.

K number K862805

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GDM 1986-09-15

LS9000 SUCTION BIOPSY NEEDLE

Applicant Engineering, Inc.

K number K862749

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GDM 1986-07-23

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE

Applicant CIVCO Medical Instruments Co., Inc.

K number K862481

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GDM 1985-11-22

MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL

Applicant Meadox Surgimed, Inc.

K number K854420

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GDM 1984-10-26

J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI

Applicant Popper & Sons, Inc.

K number K843830

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GDM 1984-10-25

ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE

Applicant Popper & Sons, Inc.

K number K843690

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GDM 1984-05-30

TRANSTHORACIC/TRANSABDOMINAL-TRAY

Applicant Applied Medical Devices, Inc.

K number K833720

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GDM 1984-05-02

BIERMAN BIOPSY NEEDLE

Applicant Popper & Sons, Inc.

K number K841299

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GDM 1983-02-23

FRANZEN NEEDLE GUIDE

Applicant Precision Dynamics Corp.

K number K830235

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GDM 1982-02-23

ISLAM BONE MARROW BIOPSY NEEDLE

Applicant Downs Surgical , Ltd.

K number K820339

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GDM 1980-03-12

FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE

Applicant A.D.T. Lab Industries

K number K800406

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GDM 1979-09-12

BONE MARROW NEEDLE

Applicant Johannah Medical Services, Inc.

K number K791643

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GDM 1978-01-03

BONE MARROW BIOPSY DEVICE

Applicant Radiation Development Co., Inc.

K number K772293

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GDM 1977-12-06

LEE ASPIRATION NEEDLE

Applicant Radiation Development Co., Inc.

K number K771574

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