FDA Product Code
FDA Product Code GDM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071732 | MARROWMINER | Stemcor Systems, Inc. | 2007-09-24 | Traditional | PDF ↗ |
| K971114 | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K953082 | ILIAC CREST BONE MARROW ASPIRATION NEEDLE | Baxter Healthcare Corp | 1995-09-22 | Traditional | PDF ↗ |
| K953064 | BIOACCESS MARROW HARVEST SYSTEM | Bioaccess, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K936207 | ENDO-NEEDLE INSTRUMENT | Gerard Medical, Inc. | 1994-06-16 | Traditional | PDF ↗ |
| K930160 | ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE | Symbiosis Corp. | 1993-07-06 | Traditional | PDF ↗ |
| K923872 | BONE MARROW BIOPSY SYSTEM | The Straumann Co. | 1992-12-15 | Traditional | PDF ↗ |
| K915572 | BECTON DICKINSON MODIFIED MENGHINI NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-03 | Traditional | PDF ↗ |
| K904667 | NA NEEDLES | Olympus Corp. | 1990-12-12 | Traditional | PDF ↗ |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Downs Surgical , Ltd. | 1990-10-31 | Traditional | PDF ↗ |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Downs Surgical , Ltd. | 1990-10-31 | Traditional | PDF ↗ |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Downs Surgical , Ltd. | 1990-10-31 | Traditional | PDF ↗ |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Downs Surgical , Ltd. | 1990-10-31 | Traditional | PDF ↗ |
| K902177 | MANAN BONE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K901995 | PLEURA BIOPSY DEVICE | Mill-Rose Laboratory | 1990-07-10 | Traditional | PDF ↗ |
| K895752 | DIAMOND BLADE SURGICAL KNIVES | Magnum Diamond, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K895594 | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | Go Medical Industries Pty. , Ltd. | 1989-10-06 | Traditional | PDF ↗ |
| K895551 | ROCKET BONE MARROW NEEDLE | A & A Medical, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K890722 | ADG BONE BIOPSY SYSTEM | American Design Group, Inc. | 1989-09-21 | Traditional | PDF ↗ |
| K891537 | CORE BIOPSY NEEDLE, CATALOG CODE #54006 | Dlp, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES | Go Medical Industries Pty. , Ltd. | 1989-03-22 | Traditional | PDF ↗ |
| K881784 | KLEIN NEEDLE | E.L. Medico Intl., Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K881783 | KLEIN HANDLE | E.L. Medico Intl., Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K883876 | WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE | E.G. Dick & Assoc. | 1988-10-07 | Traditional | PDF ↗ |
| K881624 | PLEURAL BIOPSY PUNCH NEEDLE | E.G. Dick & Assoc. | 1988-08-11 | Traditional | PDF ↗ |
| K882240 | STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC | Storz Instrument Co. | 1988-07-29 | Traditional | PDF ↗ |
| K882601 | E-Z-EM(R) LUFKIN BIOPSY NEEDLES | E-Z-Em, Inc. | 1988-07-25 | Traditional | PDF ↗ |
| K882073 | SPINAL NEEDLE | Karlin Technology, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K881730 | BREAST LOCALIZATION NEEDLES | Hart Enterprises, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K880812 | SPINAL NEEDLE | T. Korossurgical Instruments Corp. | 1988-03-11 | Traditional | PDF ↗ |
| K874928 | WHOLEY (TM) BIOPSY DEVICE | Medrad, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K873848 | RETROBULBAR NEEDLE | Healthtek, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K870523 | HAWKINS BREAST LOCALIZATION NEEDLE | N-S Medical Products | 1987-03-09 | Traditional | PDF ↗ |
| K864193 | GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN | Gaw, Inc. | 1986-11-17 | Traditional | PDF ↗ |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | Angiomed U.S., Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K862749 | LS9000 SUCTION BIOPSY NEEDLE | Engineering, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE | CIVCO Medical Instruments Co., Inc. | 1986-07-23 | Traditional | PDF ↗ |
| K854420 | MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL | Meadox Surgimed, Inc. | 1985-11-22 | Traditional | PDF ↗ |
| K843830 | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI | Popper & Sons, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K843690 | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE | Popper & Sons, Inc. | 1984-10-25 | Traditional | PDF ↗ |
| K833720 | TRANSTHORACIC/TRANSABDOMINAL-TRAY | Applied Medical Devices, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K841299 | BIERMAN BIOPSY NEEDLE | Popper & Sons, Inc. | 1984-05-02 | Traditional | PDF ↗ |
| K830235 | FRANZEN NEEDLE GUIDE | Precision Dynamics Corp. | 1983-02-23 | Traditional | PDF ↗ |
| K820339 | ISLAM BONE MARROW BIOPSY NEEDLE | Downs Surgical , Ltd. | 1982-02-23 | Traditional | PDF ↗ |
| K800406 | FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE | A.D.T. Lab Industries | 1980-03-12 | Traditional | PDF ↗ |
| K791643 | BONE MARROW NEEDLE | Johannah Medical Services, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K772293 | BONE MARROW BIOPSY DEVICE | Radiation Development Co., Inc. | 1978-01-03 | Traditional | PDF ↗ |
| K771574 | LEE ASPIRATION NEEDLE | Radiation Development Co., Inc. | 1977-12-06 | Traditional | PDF ↗ |
Product code GDM · Class I · General, Plastic Surgery. Data: openFDA.