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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167737–167760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1979
PACEMAKER PROGRAMMER
K792580 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 5d
Cleared Dec 18, 1979
SHILEY LOW PRESSURE THIN-CUFFED TRACH.
K792222 · EQN
Shiley, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 18, 1979
HEARING AID, UNITRON MODEL 905H
K792236 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Dec 18, 1979
AMIKACIN CONTROL SERUM
K792259 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
AMIKACIN LIQUID CONTROL SERUM
K792260 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
GENTAMICIN CONTROL SERUM
K792261 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
GENTAMICIN LIQUID CONTROL SERUM
K792262 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN CONTROL SERUM
K792263 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
TOBRAMYCIN LIQUID CONTROL SERUM
K792264 · LAS
Hemometrix
Toxicology · 39d
Cleared Dec 18, 1979
LIPASE TEST KIT
K792289 · CET
Mallinckrodt Critical Care
Chemistry · 35d
Cleared Dec 18, 1979
TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
K792316 · GEE
Ursus Konsult AB
General & Plastic Surgery · 32d
Cleared Dec 18, 1979
STATTEK BUN
K792328 · CDN
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Dec 18, 1979
BEHINDTHEEAR HEAR. AID MOD. 793U,M,UH,MH
K792334 · ESD
Danavox, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 18, 1979
DIATHERMIC SNARE (CRESENT TYPE)
K792343 · GEI
Mill-Rose Laboratory
General & Plastic Surgery · 29d
Cleared Dec 18, 1979
STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
K792357 · KKX
Alba-Waldensian, Inc.
General Hospital · 27d
Cleared Dec 18, 1979
FERRITIN RADIOIMMUNOASSAY
K792442 · DBF
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 19d
Cleared Dec 18, 1979
CONNECTICUT DIAGNOSTICS, LTS. DIRECT
K792465 · CIG
Connecticut Diagnostics, Ltd.
Chemistry · 15d
Cleared Dec 18, 1979
STAINS, COUNTERSTAINS & GEN. PURPOSE
K792483 · ICL
Laboratory Products, Inc.
Pathology · 29d
Cleared Dec 18, 1979
VOLU-SOL URINARY SEDIMENT STAIN
K792495 · ICF
Volu Sol Medical Industries
Pathology · 14d
Cleared Dec 18, 1979
VOLU-SOL STATIM STAIN
K792497 · IAF
Volu Sol Medical Industries
Pathology · 14d
Cleared Dec 18, 1979
TENS 4100
K792502 · GZJ
Staodynamics, Inc.
Neurology · 14d
Cleared Dec 18, 1979
FETAL CHECK
K792546 · KJR
Alta Diagnostics, Inc.
Pathology · 8d
Cleared Dec 18, 1979
FAT RED 7B STAIN SET
K792549 · HYD
Electrophoresis Corp. of America
Pathology · 8d
Cleared Dec 18, 1979
AMIDO BLACK 10B STAIN
K792552 · HZZ
Electrophoresis Corp. of America
Pathology · 8d