Panels › General, Plastic Surgery › Product code GDM · Class 1
Needle, Aspiration And Injection, Reusable
Regulation 878.4800
0510(k)s in 12 months (48 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in GDM
| Company | 510(k)s | Recalls |
|---|---|---|
| Downs Surgical , Ltd. | 5 | 0 |
| Popper & Sons, Inc. | 3 | 0 |
| Bioaccess, Inc. | 2 | 0 |
| E.G. Dick & Assoc. | 2 | 0 |
| E.L. Medico Intl., Inc. | 2 | 0 |
| Go Medical Industries Pty. , Ltd. | 2 | 0 |
| Radiation Development Co., Inc. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| A.D.T. Lab Industries | 1 | 0 |
| American Design Group, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2007 | K071732 | MARROWMINER Stemcor Systems, Inc. | GDM |
| Jun 3, 1997 | K971114 | BIOACCESS MARROW HARVEST SYSTEM Bioaccess, Inc. | GDM |
| Sep 22, 1995 | K953082 | ILIAC CREST BONE MARROW ASPIRATION NEEDLE Baxter Healthcare Corp | GDM |
| Aug 7, 1995 | K953064 | BIOACCESS MARROW HARVEST SYSTEM Bioaccess, Inc. | GDM |
| Jun 16, 1994 | K936207 | ENDO-NEEDLE INSTRUMENT Gerard Medical, Inc. | GDM |
| Jul 6, 1993 | K930160 | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE Symbiosis Corp. | GDM |
| Dec 15, 1992 | K923872 | BONE MARROW BIOPSY SYSTEM The Straumann Co. | GDM |
| Feb 3, 1992 | K915572 | BECTON DICKINSON MODIFIED MENGHINI NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | GDM |
| Dec 12, 1990 | K904667 | NA NEEDLES Olympus Corp. | GDM |
| Oct 31, 1990 | K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V Downs Surgical , Ltd., GB | GDM |
| Oct 31, 1990 | K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U Downs Surgical , Ltd., GB | GDM |
| Sep 5, 1990 | K902177 | MANAN BONE BIOPSY NEEDLE Manan Medical Products, Inc. | GDM |
| Jul 10, 1990 | K901995 | PLEURA BIOPSY DEVICE Mill-Rose Laboratory | GDM |
| Oct 17, 1989 | K895752 | DIAMOND BLADE SURGICAL KNIVES Magnum Diamond, Inc. | GDM |
| Oct 6, 1989 | K895594 | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE Go Medical Industries Pty. , Ltd., AU | GDM |
| Oct 6, 1989 | K895551 | ROCKET BONE MARROW NEEDLE A & A Medical, Inc. | GDM |
| Sep 21, 1989 | K890722 | ADG BONE BIOPSY SYSTEM American Design Group, Inc. | GDM |
| Apr 18, 1989 | K891537 | CORE BIOPSY NEEDLE, CATALOG CODE #54006 Dlp, Inc. | GDM |
| Mar 22, 1989 | K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES Go Medical Industries Pty. , Ltd., AU | GDM |
| Dec 2, 1988 | K881784 | KLEIN NEEDLE E.L. Medico Intl., Inc. | GDM |
| Dec 2, 1988 | K881783 | KLEIN HANDLE E.L. Medico Intl., Inc. | GDM |
| Oct 7, 1988 | K883876 | WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE E.G. Dick & Assoc. | GDM |
| Aug 11, 1988 | K881624 | PLEURAL BIOPSY PUNCH NEEDLE E.G. Dick & Assoc. | GDM |
| Jul 29, 1988 | K882240 | STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC Storz Instrument Co. | GDM |
| Jul 25, 1988 | K882601 | E-Z-EM(R) LUFKIN BIOPSY NEEDLES E-Z-Em, Inc. | GDM |
| Jul 18, 1988 | K882073 | SPINAL NEEDLE Karlin Technology, Inc. | GDM |
| May 13, 1988 | K881730 | BREAST LOCALIZATION NEEDLES Hart Enterprises, Inc. | GDM |
| Mar 11, 1988 | K880812 | SPINAL NEEDLE T. Korossurgical Instruments Corp. | GDM |
| Dec 30, 1987 | K874928 | WHOLEY (TM) BIOPSY DEVICE Medrad, Inc. | GDM |
| Oct 23, 1987 | K873848 | RETROBULBAR NEEDLE Healthtek, Inc. | GDM |
| Mar 9, 1987 | K870523 | HAWKINS BREAST LOCALIZATION NEEDLE N-S Medical Products | GDM |
| Nov 17, 1986 | K864193 | GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN Gaw, Inc. | GDM |
| Sep 29, 1986 | K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE Angiomed U.S., Inc. | GDM |
| Sep 15, 1986 | K862749 | LS9000 SUCTION BIOPSY NEEDLE Engineering, Inc. | GDM |
| Jul 23, 1986 | K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE CIVCO Medical Instruments Co., Inc. | GDM |
| Nov 22, 1985 | K854420 | MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL Meadox Surgimed, Inc. | GDM |
| Oct 26, 1984 | K843830 | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI Popper & Sons, Inc. | GDM |
| Oct 25, 1984 | K843690 | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE Popper & Sons, Inc. | GDM |
| May 30, 1984 | K833720 | TRANSTHORACIC/TRANSABDOMINAL-TRAY Applied Medical Devices, Inc. | GDM |
| May 2, 1984 | K841299 | BIERMAN BIOPSY NEEDLE Popper & Sons, Inc. | GDM |
| Feb 23, 1983 | K830235 | FRANZEN NEEDLE GUIDE Precision Dynamics Corp. | GDM |
| Feb 23, 1982 | K820339 | ISLAM BONE MARROW BIOPSY NEEDLE Downs Surgical , Ltd. | GDM |
| Mar 12, 1980 | K800406 | FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE A.D.T. Lab Industries | GDM |
| Sep 12, 1979 | K791643 | BONE MARROW NEEDLE Johannah Medical Services, Inc. | GDM |
| Jan 3, 1978 | K772293 | BONE MARROW BIOPSY DEVICE Radiation Development Co., Inc. | GDM |
| Dec 6, 1977 | K771574 | LEE ASPIRATION NEEDLE Radiation Development Co., Inc. | GDM |
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