Atlas FDA

GAA

107 FDA 510(k) clearances · Product code

44 daysmedian time to decision
90 days90th percentile
107clearances measured

FDA profile

Official device name
Needle, Aspiration And Injection, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 108 · 2022: 74 · 2023: 118 · 2024: 181 · 2025: 351 · 2026: 121
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CapnoSpot™ Pneumothorax Decompression Indicator (K223625)Pneumeric, Inc.2023-03-28
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (K102274)Arvik Enterprises/ Mini Lap Technologies2011-06-15
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (K011586)Diametrics Medical, Inc.2001-11-16
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (K994151)Ximed/Prosure/Injectx2000-03-01
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (K983200)Ximed/Prosure/Injectx1998-12-11
MANAN ACCURA NEEDLE (K974741)Medical Device Technologies, Inc.1998-01-08
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (K962425)Radi Medical Systems AB1996-09-11
MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K961959)Medical Device Technologies, Inc.1996-07-19
MONOJECT BONE MARROW BIOPSY TRAYS (K945109)Sherwood Medical Co.1994-11-14
MANAN BONE MARROW HARVEST NEEDLES (K940025)Manan Medical Products, Inc.1994-02-25
MANAN GENERAL PURPOSE INTRODUCER NEEDLE (K940024)Manan Medical Products, Inc.1994-02-25
BONE MARROW BIOPSY PROCEDURE TRAY (K930158)Symbiosis Corp.1993-07-02
IRRIGATION/ASPIRATION TUBING SET (K925621)Kirwan Surgical Products, Inc.1993-05-07
GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE (K924501)Symbiosis Corp.1993-04-20
SYMBIOSIS BONE MARROW BIOPSY NEEDLE (K925416)Symbiosis Corp.1993-02-23
TURKEL THORACENTESIS SYSTEM (K922614)Symbiosis Corp.1992-07-30
KOPAN'S TARGET (K915417)Medical Device Technologies, Inc.1992-01-14
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 (K914608)Dlp, Inc.1992-01-09
ASPIRATION/INJECTION NEEDLE (K913992)Northgate Technologies, Inc.1991-10-30
BONE MARROW BIOPSY TRAY (K912074)Manan Medical Products, Inc.1991-08-28
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES (K910036)Surgical Technologies, Inc.1991-04-04
REDDICK IRRIGATION/ASPIRATION SYSTEM (K910117)Ideal Medical, Inc.1991-03-19
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE (K901438)Telemed Systems, Inc.1990-05-24
WILSON-COOK LUNG BIOPSY NEEDLE (K897050)Wilson-Cook Medical, Inc.1990-04-16
JACKSON FINE NEEDLE ASPIRATION SYSTEM (K896606)National-Standard Medical Products1990-01-04
KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) (K896605)National-Standard Medical Products1990-01-04
MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. (K896019)Dlp, Inc.1990-01-03
E-Z-EM VACUUM ASPIRATION SYRINGE (K895012)E-Z-Em, Inc.1989-12-27
16 GA X 10 BULLET POINT NEEDLE (K894873)R. J. Doyle, Inc.1989-09-22
20GA X 7-1/2 THREADING BULLET POINT NEEDLE (K894875)R. J. Doyle, Inc.1989-09-22
14 INCH BULLET POINT NEEDLE (K894874)R. J. Doyle, Inc.1989-09-22
16 GA X 6 BULLET POINT NEEDLE (K894872)R. J. Doyle, Inc.1989-09-22
THORACENTISIS KIT (K894326)Mill-Rose Laboratory1989-07-24
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED (K883014)Sherwood Medical Co.1988-07-28
CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM (K882105)Dianon Systems, Inc.1988-07-11
NOVO VIVO MODEL #17140 AND #17135 (K880377)Genesis Industries, Inc.1988-04-04
PRIA-KIT (TM) PRIAPISM KIT S.S. (K874000)Canton Medical, Inc.1987-12-30
ANCHOR BIOPSY NEEDLE (K873124)Anchor Products Co.1987-09-08
MEDSURG CHIBA PTC NEEDLE (K870893)Medsurg Industries, Inc.1987-03-25
NOTCH-NEEDLE, WESCOTT STYLE (K870896)Ocean Medical Products, Ltd.1987-03-18
NAMIC CHIBA ASPIRATION BIOPSY NEEDLE (K864800)North American Instrument Corp.1987-02-06
RANFAC CUT BIOPSY NEEDLE (K864139)Ranfac, Corp.1986-11-05
MANAN BREST TUMOR LOCALIZATION NEEDLE (K863848)Manan Manufacturing Co., Inc.1986-10-14
BONE MARROW TRAY (K863326)Packaging Technologies, Inc.1986-09-16
TBI NEEDLE (K860582)Hobbs Medical, Inc.1986-03-04
ANGIOMED FINE NEEDLES AND NEEDLE SET (K855141)Angiomed U.S., Inc.1986-01-24
HYPODERMIC NEEDLE AND STYLET (K854579)Berkley and Co.1985-12-17
NEEDLE W/STYLET FOR IMPLANTATION (K854238)Microvasive1985-11-13
EROSA DISPOSABLE HYPODERMIC NEEDLE (K853980)Rose KG1985-10-18
LEE BONE MARROW BIOPSY/ASPIRATION TRAY (K852897)Southland Instruments, Inc.1985-08-21
STERILE, DISPOSABLE NEEDLE (K852817)Fabersanitas, S.A.1985-07-26
MANAN TROCAR STYLE BIOPSY NEEDLE (K852426)Manan Manufacturing Co., Inc.1985-06-27
MANAN SPINAL NEEDLE (K852427)Manan Manufacturing Co., Inc.1985-06-27
HAWKIN NEEDLE (K851953)Wilson-Cook Medical, Inc.1985-05-17
CHIBA NEEDLE (K851957)Wilson-Cook Medical, Inc.1985-05-17
GILL'S IRRIGATOR/ASPIRATOR NEEDLE (K843925)Concept, Inc.1984-11-05
CORMED HUBER POINT NEEDLE (K843083)Cormed, Inc., Sub. C.R.Bard, Inc.1984-09-05
AIMED DISPOS. INJECTION NEEDLE (K842230)Tech-Cons Ltd., Intl.1984-08-17
LEE BONE MARROW NEEDLES (K842106)Southland Instruments, Inc.1984-08-10
ISLAM BONE MARROW ASPIRATION NEEDLES (K842699)Downs Surgical , Ltd.1984-08-02
GARDNER TYPE BONE MARROW NEEDLE (K841301)Popper & Sons, Inc.1984-06-05
INTRADISCAL THERAPY NEEDLE 18 GAUGE (K840922)Dlp, Inc.1984-04-24
TOP STERILE DISPOS. HYPODERMIC NEEDLES (K832626)Top Surgical Manufacturers Co.1983-10-14
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 (K831392)Travenol Laboratories, S.A.1983-07-12
STERILE, DISPOSABLE, HYPODERMIC NEEDLES (K830378)Abco Dealers, Inc.1983-03-24
INJECTION ASPIRATING NEEDLES (K821697)American Endoscopy, Inc.1982-06-25
VARIOUS STERILE BIOPSY ASPIRATION NEED (K821017)Medsurg Industries, Inc.1982-06-22
HYPODERMIC NEEDLES & SYRINGES (K821348)Medi-Tech, Inc.1982-06-10
SILOAM SAVE-A-NEEDLE (K820502)Siloam, Inc.1982-03-15
MSI STERNUM ASPIRATION NEEDLE (K820070)Creative Research and Mfg., Inc.1982-02-04
POTTS-COURNAND STYLE NEEDLE (K813448)Ocean Medical Products, Ltd.1982-01-07
CHIBA SKINNY NEEDLE (K813460)Ocean Medical Products, Ltd.1982-01-07
CUATICO MYELOGRAPHY NEEDLES (K813367)Dlp, Inc.1982-01-05
DISPOSABLE CHIBA-TYPE NEEDLE (K813368)Dlp, Inc.1982-01-05
A.D.T. REUSABLE BONE MARROW NEEDLE (K811771)Lab Industries, Inc.1981-07-10
MSI BONE MARROW BIOPSY NEEDLE W/J TIP (K810248)Creative Research and Mfg., Inc.1981-03-20
PHERESIS NEEDLE ASSEMBLY (K810076)Haemonetics Corp.1981-03-05
ADT BONE MARROW BIOPSY-ASPIR. NEELDE (K801753)A.D.T. Lab Industries1980-08-20
ADT BONE MARROW ASPIRATION NEEDLE (K801754)A.D.T. Lab Industries1980-08-20
ACCU-CORE DISPOSABLE BIOPSY NEEDLE (K801457)Medline Industries, Inc.1980-07-14
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL (K800417)A.D.T. Lab Industries1980-04-28
ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW (K800412)A.D.T. Lab Industries1980-04-28
ADT SOFT TISSUE BIOPSY TRAY (K800414)A.D.T. Lab Industries1980-04-28
ADT BONE MARROW BIOPSY ASPIRATION TRAY (K800409)A.D.T. Lab Industries1980-04-28
ADT BONE MARROW BIOPSY-ASPIRATION TRAY (K800410)A.D.T. Lab Industries1980-04-28
ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE (K800408)A.D.T. Lab Industries1980-04-28
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS (K800411)A.D.T. Lab Industries1980-04-28
FERRIS MODIFIED DISP. IL STERNAL-ILIAC (K800413)A.D.T. Lab Industries1980-03-25
ADT NERVE BLOCK TRAY(DISP.) (K800423)A.D.T. Lab Industries1980-03-25
ADT MENGHINI TYPE SOFT TISSUE BIOPSY (K800415)A.D.T. Lab Industries1980-03-25
ADT PERITONEAL LAVAGE TRAY (DISP.) (K800421)A.D.T. Lab Industries1980-03-25
FERRIS BONE MARROW -NEEDLE-(DISPOSABLE) (K800407)A.D.T. Lab Industries1980-03-12
EXTEMP/EXTEMP-V (K800153)Pharma-Filter, Inc.1980-02-06
BURRON VENTED NEEDLE (K790472)National Patent Development Corp.1979-03-26
NEEDLE II, BURRON FILTER (K790060)National Patent Development Corp.1979-03-21
NEEDLE, WITH FILTER (K790142)National Patent Development Corp.1979-02-26
NEEDLE, BURRON FILTER (K790061)National Patent Development Corp.1979-02-16
NEEDLE, BLOOD COLLECTING (K790079)Jelco Laboratories1979-02-01
BONE MARROW ASPIRATION KIT (K781371)Ferris Mfg. Corp.1978-09-20
PAB CONVENIENCE TRAY (K781264)Waters Assoc., Inc.1978-09-20
Next →

Track GAA automatically

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