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
48 devices
25–48 of 48
Cleared Aug 11, 1988
PLEURAL BIOPSY PUNCH NEEDLE
K881624
E.G. Dick & Assoc.
General & Plastic Surgery · 121d
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 May 13, 1988
BREAST LOCALIZATION NEEDLES
K881730
Hart Enterprises, Inc.
General & Plastic Surgery · 21d
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 Oct 23, 1987
RETROBULBAR NEEDLE
K873848
Healthtek, Inc.
General & Plastic Surgery · 31d
Cleared Mar 09, 1987
HAWKINS BREAST LOCALIZATION NEEDLE
K870523
N-S Medical Products
General & Plastic Surgery · 31d
Cleared Nov 17, 1986
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN
K864193
Gaw, Inc.
General & Plastic Surgery · 21d
Cleared Sep 29, 1986
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805
Angiomed U.S., Inc.
General & Plastic Surgery · 69d
Cleared Sep 15, 1986
LS9000 SUCTION BIOPSY NEEDLE
K862749
Engineering, Inc.
General & Plastic Surgery · 56d
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 Oct 26, 1984
J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI
K843830
Popper & Sons, Inc.
General & Plastic Surgery · 25d
Cleared Oct 25, 1984
ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
K843690
Popper & Sons, Inc.
General & Plastic Surgery · 36d
Cleared May 30, 1984
TRANSTHORACIC/TRANSABDOMINAL-TRAY
K833720
Applied Medical Devices, Inc.
General & Plastic Surgery · 219d
Cleared May 02, 1984
BIERMAN BIOPSY NEEDLE
K841299
Popper & Sons, Inc.
General & Plastic Surgery · 33d
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
Cleared Mar 12, 1980
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE
K800406
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Sep 12, 1979
BONE MARROW NEEDLE
K791643
Johannah Medical Services, Inc.
General & Plastic Surgery · 20d
Cleared Jan 03, 1978
BONE MARROW BIOPSY DEVICE
K772293
Radiation Development Co., Inc.
General & Plastic Surgery · 22d
Cleared Dec 06, 1977
LEE ASPIRATION NEEDLE
K771574
Radiation Development Co., Inc.
General & Plastic Surgery · 113d