FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
109393–109416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1994
SURGICAL INSTRUMENT, DISPOSABLE
K940684 · MDM
Her-Mar, Inc.
General & Plastic Surgery · 32d
Cleared Mar 11, 1994
BIP-COAX-SYSTEM
K915801 · FCG
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 808d
Cleared Mar 11, 1994
FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE
K915857 · HET
Olympus Corp.
Obstetrics & Gynecology · 805d
Cleared Mar 11, 1994
DISPOSIBLE ELECTRO COAGULATION PROBE
K924057 · GEI
Endoscopic Technologies, Inc.
General & Plastic Surgery · 576d
Cleared Mar 11, 1994
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
K924715 · MDK
Gen-Probe, Inc.
Microbiology · 536d
Cleared Mar 11, 1994
ARTHREX TIBIAL TUNNEL CANNULA
K930152 · HRX
Arthrex, Inc.
Orthopedic · 423d
Cleared Mar 11, 1994
FLEXIBLE EXTENDER
K930243 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 416d
Cleared Mar 11, 1994
ENDOPATH RELOADABLE LINEAR CUTTER
K930934 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 381d
Cleared Mar 11, 1994
INFANT WARMER
K931529 · FMT
Medix I.C.S.A.
General Hospital · 350d
Cleared Mar 11, 1994
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
K931557 · GRZ
Fuller Laboratories, Inc.
Microbiology · 346d
Cleared Mar 11, 1994
COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.
K931900 · DQK
Archival Technologies, Inc.
Cardiovascular · 326d
Cleared Mar 11, 1994
ERYTHROPOIETIN IMMUNOASSAY KIT
K932650 · GGT
Nichols Institute
Hematology · 282d
Cleared Mar 11, 1994
RETRACTORS AND SCRAPER
K933008 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 263d
Cleared Mar 11, 1994
DANNIFLEX CPM 600
K933394 · BXB
Danninger Medical Technology, Inc.
Physical Medicine · 242d
Cleared Mar 11, 1994
CYTOLOGY BRUSH
K933628 · HHT
Bioteque America, Inc.
Obstetrics & Gynecology · 227d
Cleared Mar 11, 1994
SIGMA CALCIUM REAGENT
K933678 · CJY
Sigma Chemical Co.
Chemistry · 225d
Cleared Mar 11, 1994
GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES
K934316 · LYY
Contract Latex Dippers Sdn Bhd
General Hospital · 191d
Cleared Mar 11, 1994
CREATININE-S ASSAY
K934587 · CGX
Diagnostic Chemicals , Ltd.
Chemistry · 169d
Cleared Mar 11, 1994
SEPP ADHESIVE REMOVER
K934790 · KOX
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 157d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Mar 11, 1994
EEC PROBE
K935115 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 137d
Cleared Mar 11, 1994
YOKE ASSEMBLY MEDICAL GAS
K935283 · CAM
American Gage & Medical, Inc.
Anesthesiology · 128d
Cleared Mar 11, 1994
TYTIN
K935535 · EJJ
Kerr Corporation (Danbury)
Dental · 115d
Cleared Mar 11, 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · DLZ
Baxter Diagnostics, Inc.
Toxicology · 113d