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
150241–150264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
K842847 · CJW
Wako Chemicals USA, Inc.
Hematology · 144d
Cleared Dec 11, 1984
COOPERVISION SYSTEM VI
K842945 · HQC
CooperVision, Inc.
Ophthalmic · 139d
Cleared Dec 11, 1984
KARL STORZ 27086KC ULTRASONIC LITHOTRI
K843101 · FEO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d
Cleared Dec 11, 1984
OVUSTICK SELF-TEST
K843284 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Dec 11, 1984
CHEW-DENT
K843406 · JEW
Senair-Mot
Dental · 102d
Cleared Dec 11, 1984
CORNING 614 NA/K ANALYZER
K843530 · JGS
Corning Medical & Scientific
Chemistry · 95d
Cleared Dec 11, 1984
HEARING AID - ALL IN THE EAR
K843574 · ESD
Auralogics Lab
Ear, Nose, Throat · 91d
Cleared Dec 11, 1984
PROM NAID
K843581 · ITH
Lossing Orthopedic, Inc.
Physical Medicine · 91d
Cleared Dec 11, 1984
WOODLYN CLASSIC CATARACT ACUITY TEST
K843812 · HLI
Woodlyn, Inc.
Ophthalmic · 74d
Cleared Dec 11, 1984
CANMED 103 9300 ELECTRODE
K844097 · GXY
Medtronic Vascular
Neurology · 49d
Cleared Dec 11, 1984
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K844150 · HQC
American Medical Optics
Ophthalmic · 48d
Cleared Dec 11, 1984
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · KLS
Bd Becton Dickinson Vacutainer...
Toxicology · 47d
Cleared Dec 11, 1984
EMIT QST ETHOSUXIMIDE ASSAY
K844204 · DLF
Syva Co.
Toxicology · 42d
Cleared Dec 11, 1984
AUTOTRACTION TABLE
K844233 · JFB
Chattanooga Group, Inc.
Physical Medicine · 41d
Cleared Dec 11, 1984
COE-LITE POLYMERIZATION UNIT
K844325 · EBZ
Coe Laboratories, Inc.
Dental · 34d
Cleared Dec 11, 1984
OPHTHALMIC CHAIR
K844362 · HMF
Luneau Laboratories
Ophthalmic · 28d
Cleared Dec 11, 1984
O.M.S. GUILLOTINE CUTTER
K844374 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 28d
Cleared Dec 11, 1984
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · CGI
Amersham Corp.
Chemistry · 27d
Cleared Dec 11, 1984
TRIGLYCERIDE CALIBRATOR
K844468 · JIT
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Dec 11, 1984
OMS SCISSORS
K844510 · HQE
Optical Micro Systems, Inc.
Ophthalmic · 21d
Cleared Dec 11, 1984
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · HNN
Codman & Shurtleff, Inc.
Ophthalmic · 20d
Cleared Dec 11, 1984
REFERRIL CALIBRATORS
K844585 · JIX
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
K844586 · JJF
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Dec 11, 1984
SIEGEN SURFACE ELECTRODES
K844646 · GXY
Siegen Corp.
Neurology · 12d