GDM · Class I · 21 CFR 878.4800

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

Leading manufacturers include Downs Surgical , Ltd., Popper & Sons, Inc. and Radiation Development Co., 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 Aug 07, 1995
BIOACCESS MARROW HARVEST SYSTEM
K953064
Bioaccess, Inc.
General & Plastic Surgery · 38d
Cleared Jun 16, 1994
ENDO-NEEDLE INSTRUMENT
K936207
Gerard Medical, Inc.
General & Plastic Surgery · 169d
Cleared Jul 06, 1993
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
K930160
Symbiosis Corp.
General & Plastic Surgery · 174d
Cleared Dec 15, 1992
BONE MARROW BIOPSY SYSTEM
K923872
The Straumann Co.
General & Plastic Surgery · 134d
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 17, 1989
DIAMOND BLADE SURGICAL KNIVES
K895752
Magnum Diamond, Inc.
General & Plastic Surgery · 21d
Cleared Oct 06, 1989
ROCKET BONE MARROW NEEDLE
K895551
A & A Medical, Inc.
General & Plastic Surgery · 23d
Cleared Oct 06, 1989
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
K895594
Go Medical Industries Pty. , Ltd.
General & Plastic Surgery · 21d
Cleared Sep 21, 1989
ADG BONE BIOPSY SYSTEM
K890722
American Design Group, Inc.
General & Plastic Surgery · 220d
Cleared Apr 18, 1989
CORE BIOPSY NEEDLE, CATALOG CODE #54006
K891537
Dlp, Inc.
General & Plastic Surgery · 32d
Cleared Mar 22, 1989
ASPIRATING AND IRRIGATING CYSTS NEEDLES
K885283
Go Medical Industries Pty. , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 02, 1988
KLEIN HANDLE
K881783
E.L. Medico Intl., Inc.
General & Plastic Surgery · 220d
Cleared Dec 02, 1988
KLEIN NEEDLE
K881784
E.L. Medico Intl., Inc.
General & Plastic Surgery · 219d
Cleared Oct 07, 1988
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE
K883876
E.G. Dick & Assoc.
General & Plastic Surgery · 24d

About Product Code GDM - Regulatory Context