Atlas FDA

GDM

48 FDA 510(k) clearances · Product code

56 daysmedian time to decision
174 days90th percentile
48clearances measured

FDA profile

Official device name
Needle, Aspiration And Injection, Reusable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
1997: 2 · 1998: 1 · 1999: 2 · 2001: 2 · 2003: 2 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MARROWMINER (K071732)Stemcor Systems, Inc.2007-09-24
BIOACCESS MARROW HARVEST SYSTEM (K971114)Bioaccess, Inc.1997-06-03
ILIAC CREST BONE MARROW ASPIRATION NEEDLE (K953082)Baxter Healthcare Corp1995-09-22
BIOACCESS MARROW HARVEST SYSTEM (K953064)Bioaccess, Inc.1995-08-07
ENDO-NEEDLE INSTRUMENT (K936207)Gerard Medical, Inc.1994-06-16
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (K930160)Symbiosis Corp.1993-07-06
BONE MARROW BIOPSY SYSTEM (K923872)The Straumann Co.1992-12-15
BECTON DICKINSON MODIFIED MENGHINI NEEDLE (K915572)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-03
NA NEEDLES (K904667)Olympus Corp.1990-12-12
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (K903747)Downs Surgical , Ltd.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (K903750)Downs Surgical , Ltd.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (K903749)Downs Surgical , Ltd.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (K903748)Downs Surgical , Ltd.1990-10-31
MANAN BONE BIOPSY NEEDLE (K902177)Manan Medical Products, Inc.1990-09-05
PLEURA BIOPSY DEVICE (K901995)Mill-Rose Laboratory1990-07-10
DIAMOND BLADE SURGICAL KNIVES (K895752)Magnum Diamond, Inc.1989-10-17
ROCKET BONE MARROW NEEDLE (K895551)A & A Medical, Inc.1989-10-06
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (K895594)Go Medical Industries Pty. , Ltd.1989-10-06
ADG BONE BIOPSY SYSTEM (K890722)American Design Group, Inc.1989-09-21
CORE BIOPSY NEEDLE, CATALOG CODE #54006 (K891537)Dlp, Inc.1989-04-18
ASPIRATING AND IRRIGATING CYSTS NEEDLES (K885283)Go Medical Industries Pty. , Ltd.1989-03-22
KLEIN HANDLE (K881783)E.L. Medico Intl., Inc.1988-12-02
KLEIN NEEDLE (K881784)E.L. Medico Intl., Inc.1988-12-02
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE (K883876)E.G. Dick & Assoc.1988-10-07
PLEURAL BIOPSY PUNCH NEEDLE (K881624)E.G. Dick & Assoc.1988-08-11
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC (K882240)Storz Instrument Co.1988-07-29
E-Z-EM(R) LUFKIN BIOPSY NEEDLES (K882601)E-Z-Em, Inc.1988-07-25
SPINAL NEEDLE (K882073)Karlin Technology, Inc.1988-07-18
BREAST LOCALIZATION NEEDLES (K881730)Hart Enterprises, Inc.1988-05-13
SPINAL NEEDLE (K880812)T. Korossurgical Instruments Corp.1988-03-11
WHOLEY (TM) BIOPSY DEVICE (K874928)Medrad, Inc.1987-12-30
RETROBULBAR NEEDLE (K873848)Healthtek, Inc.1987-10-23
HAWKINS BREAST LOCALIZATION NEEDLE (K870523)N-S Medical Products1987-03-09
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN (K864193)Gaw, Inc.1986-11-17
ANGIOMED VAC-U-CUT BIOPSY NEEDLE (K862805)Angiomed U.S., Inc.1986-09-29
LS9000 SUCTION BIOPSY NEEDLE (K862749)Engineering, Inc.1986-09-15
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE (K862481)CIVCO Medical Instruments Co., Inc.1986-07-23
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL (K854420)Meadox Surgimed, Inc.1985-11-22
J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI (K843830)Popper & Sons, Inc.1984-10-26
ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE (K843690)Popper & Sons, Inc.1984-10-25
TRANSTHORACIC/TRANSABDOMINAL-TRAY (K833720)Applied Medical Devices, Inc.1984-05-30
BIERMAN BIOPSY NEEDLE (K841299)Popper & Sons, Inc.1984-05-02
FRANZEN NEEDLE GUIDE (K830235)Precision Dynamics Corp.1983-02-23
ISLAM BONE MARROW BIOPSY NEEDLE (K820339)Downs Surgical , Ltd.1982-02-23
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE (K800406)A.D.T. Lab Industries1980-03-12
BONE MARROW NEEDLE (K791643)Johannah Medical Services, Inc.1979-09-12
BONE MARROW BIOPSY DEVICE (K772293)Radiation Development Co., Inc.1978-01-03
LEE ASPIRATION NEEDLE (K771574)Radiation Development Co., Inc.1977-12-06

Track GDM automatically

Every clearance here is in the API, with alerts when new ones post.