GDM · Class I · 21 CFR 878.4800

FDA Product Code GDM: Needle, Aspiration And Injection, Reusable

Leading manufacturers include Downs Surgical , Ltd., Bioaccess, Inc. and Meadox Surgimed, Inc..

48
Total
48
Cleared
70d
Avg days
1977
Since

FDA 510(k) Cleared Needle, Aspiration And Injection, Reusable Devices (Product Code GDM)

48 devices
1–24 of 48
Cleared Sep 24, 2007
MARROWMINER
K071732
Stemcor Systems, Inc.
General & Plastic Surgery · 90d
Cleared Jun 03, 1997
BIOACCESS MARROW HARVEST SYSTEM
K971114
Bioaccess, Inc.
General & Plastic Surgery · 69d
Cleared Sep 22, 1995
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082
Baxter Healthcare Corp
General & Plastic Surgery · 81d
Cleared Jul 06, 1993
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
K930160
Symbiosis Corp.
General & Plastic Surgery · 174d
Cleared Feb 03, 1992
BECTON DICKINSON MODIFIED MENGHINI NEEDLE
K915572
Bd Becton Dickinson Vacutainer Systems Preanalytic
General & Plastic Surgery · 53d
Cleared Dec 12, 1990
NA NEEDLES
K904667
Olympus Corp.
General & Plastic Surgery · 58d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
K903747
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V
K903748
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U
K903749
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Oct 31, 1990
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E
K903750
Downs Surgical , Ltd.
General & Plastic Surgery · 76d
Cleared Sep 05, 1990
MANAN BONE BIOPSY NEEDLE
K902177
Manan Medical Products, Inc.
General & Plastic Surgery · 113d
Cleared Jul 10, 1990
PLEURA BIOPSY DEVICE
K901995
Mill-Rose Laboratory
General & Plastic Surgery · 69d
Cleared Oct 06, 1989
ROCKET BONE MARROW NEEDLE
K895551
A & A Medical, Inc.
General & Plastic Surgery · 23d
Cleared Apr 18, 1989
CORE BIOPSY NEEDLE, CATALOG CODE #54006
K891537
Dlp, Inc.
General & Plastic Surgery · 32d
Cleared Jul 29, 1988
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC
K882240
Storz Instrument Co.
General & Plastic Surgery · 63d
Cleared Jul 25, 1988
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
K882601
E-Z-Em, Inc.
General & Plastic Surgery · 31d
Cleared Jul 18, 1988
SPINAL NEEDLE
K882073
Karlin Technology, Inc.
General & Plastic Surgery · 62d
Cleared Mar 11, 1988
SPINAL NEEDLE
K880812
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 14d
Cleared Dec 30, 1987
WHOLEY (TM) BIOPSY DEVICE
K874928
Medrad, Inc.
General & Plastic Surgery · 28d
Cleared Sep 29, 1986
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805
Angiomed U.S., Inc.
General & Plastic Surgery · 69d
Cleared Jul 23, 1986
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
K862481
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 23d
Cleared Nov 22, 1985
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL
K854420
Meadox Surgimed, Inc.
General & Plastic Surgery · 18d
Cleared Feb 23, 1983
FRANZEN NEEDLE GUIDE
K830235
Precision Dynamics Corp.
General & Plastic Surgery · 29d
Cleared Feb 23, 1982
ISLAM BONE MARROW BIOPSY NEEDLE
K820339
Downs Surgical , Ltd.
General & Plastic Surgery · 15d

About Product Code GDM - Regulatory Context