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
151609–151632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1984
RIONET HEARING AID HI-03
K841935 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 95d
Cleared Aug 14, 1984
MIC GASTROSTOMY TUBE
K842076 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 83d
Cleared Aug 14, 1984
VENTREZYME PHENOBARBITAL KIT IMMUNO
K842264 · DLZ
Ventrex Laboratories, Inc.
Toxicology · 68d
Cleared Aug 14, 1984
ULTRASONIC COOL SPRAY HUMIDIFIER
K842275 · KFZ
Sunbeam Corp.
Anesthesiology · 67d
Cleared Aug 14, 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · KNT
Y
Gastroenterology & Urology · 42d
Cleared Aug 14, 1984
HOOK PUNCH FORCEPS FOR ARTHROSCOPY
K842819 · HTD
Medtech Industries, Inc.
General & Plastic Surgery · 26d
Cleared Aug 14, 1984
ARTHROSCOPY KNIVES
K842820 · HTS
Medtech Industries, Inc.
Orthopedic · 26d
Cleared Aug 14, 1984
VIVONEX TUNG STEN TIP TUBE
K842841 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 14, 1984
MED. 199 CATALOG M3769 W/EARLE'S SALT
K843043 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 14, 1984
MINIM. ESSENTIAL MED. EAGLE M4144 W/
K843044 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 12, 1984
FLUSH DEVICE
K833170 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 331d
Cleared Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527 · LKT
Ortho Diagnostic Systems, Inc.
Microbiology · 122d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION CATH.
K841639 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION INFUSION
K841640 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
TOYO JOZO URIC ACID TEST
K842103 · KNK
Advocacy International, Ltd.
Chemistry · 79d
Cleared Aug 12, 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · CIT
Sigma Chemical Co.
Chemistry · 54d
Cleared Aug 12, 1984
AST/GOT REAGENT SET UV RATE
K842521 · CIT
Sterling Biochemical, Inc.
Chemistry · 46d
Cleared Aug 12, 1984
IMMPULSE CORTISOL ASSAY REAGENTS
K842554 · CGR
Aktis Corp.
Chemistry · 41d
Cleared Aug 12, 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · CKA
Sigma Chemical Co.
Chemistry · 41d
Cleared Aug 12, 1984
SOPHEIA/MP DIGITOXIN EIA KIT
K842578 · LFM
Diagnostic Products Corp.
Toxicology · 40d
Cleared Aug 12, 1984
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · JFL
Shaban Mfg. Co.
Chemistry · 33d
Cleared Aug 12, 1984
EMIT LOW & MEDIUM CALIBRATORS A
K842673
Syva Co.
Toxicology · 33d
Cleared Aug 12, 1984
NEW METHYLENE BLUE N
K842743 · KFC
E K Ind., Inc.
Hematology · 30d
Cleared Aug 12, 1984
WRIGHT STAIN
K842744 · IAF
E K Ind., Inc.
Pathology · 30d