FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132337–132360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1989
1570 - FETAL BLOOD SAMPLING KIT
K891388 · HGW
Transidyne General Corp.
Obstetrics & Gynecology · 14d
Cleared Mar 27, 1989
CYTOMEGALOVIRUS IGG EIA KIT
K880433 · LFZ
De Ferris Laboratories, Inc.
Microbiology · 420d
Cleared Mar 27, 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399 · LFZ
United Biotech, Inc.
Microbiology · 228d
Cleared Mar 27, 1989
FRANKLIN COLLECTOR(R)
K884612 · FQZ
Franklin Diagnostics, Inc.
General Hospital · 143d
Cleared Mar 27, 1989
ANAEROBIC MIC PANEL
K884831 · JWY
Microtech Medical Systems, Inc.
Microbiology · 129d
Cleared Mar 27, 1989
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · FJS
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Mar 27, 1989
ABBOTT TESTPACK(TM) D-DIMER
K890422 · GHH
Abbott Laboratories
Hematology · 60d
Cleared Mar 27, 1989
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K890530 · DGC
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Mar 27, 1989
VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
K890840 · GTZ
Adi Diagnostics, Inc.
Microbiology · 34d
Cleared Mar 24, 1989
ACCESSORY TO EYEDROP GUIDE
K884974 · JYJ
Suredrop, Inc.
Ear, Nose, Throat · 114d
Cleared Mar 24, 1989
GAMMA-GLUTAMYLTRANSFERASE
K890312 · JQB
American Monitor Corp.
Chemistry · 60d
Cleared Mar 24, 1989
LATEX EXAMINATION GLOVE
K890462 · LYY
C.R. Trading, Inc.
General Hospital · 53d
Cleared Mar 24, 1989
INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
K890509 · HQF
Biophysic Medical, Inc.
Ophthalmic · 51d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · CEP
Abbott Laboratories
Chemistry · 51d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · CJE
Abbott Laboratories
Chemistry · 50d
Cleared Mar 24, 1989
KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
K890573 · JIY
Kenlor Industries, Inc.
Chemistry · 46d
Cleared Mar 24, 1989
O-020 LASER INDIRECT OPHTHALMOSCOPE
K890787 · HGF
Hgm Medical Laser Systems, Inc.
Obstetrics & Gynecology · 37d
Cleared Mar 24, 1989
HEXASCAN SCANNER HANDPIECE
K890865 · GEX
Metatech Corp.
General & Plastic Surgery · 31d
Cleared Mar 24, 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · KHO
Baxter Healthcare Corp
Chemistry · 29d
Cleared Mar 24, 1989
TEXMED LATEX EXAMINATION GLOVE
K891120 · LYY
Transcorp
General Hospital · 22d
Cleared Mar 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891424 · LYY
Oon Corp. Resources
General Hospital · 10d
Cleared Mar 24, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891434 · LYY
Sime Darby USA
General Hospital · 9d
Cleared Mar 23, 1989
POLYMER ADHESIVE BANDAGE
K883391 · NAD
Marion Laboratories, Inc.
General & Plastic Surgery · 226d
Cleared Mar 23, 1989
TURBO AIR COMPRESSOR 8000
K883829 · BTI
Necon Medical, Inc.
Anesthesiology · 195d