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
138937–138960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1987
FILM AND PAPER COMBINATION STERILIZING BAG
K871798 · FRG
Cost Rite Health Products, Inc.
General Hospital · 75d
Cleared Jul 21, 1987
TWO FLUID W/CHECK VALVE
K871843 · FPA
Panamedix, Inc.
General Hospital · 70d
Cleared Jul 21, 1987
HSC UNIT ROD
K871870 · KWP
Research Development Corp.
Orthopedic · 69d
Cleared Jul 21, 1987
IMPERVA-P
K871898 · EBF
Shofu Dental Corp.
Dental · 67d
Cleared Jul 21, 1987
IMPERVA-A
K871899 · EBF
Shofu Dental Corp.
Dental · 67d
Cleared Jul 21, 1987
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
K871972 · DGE
American Dade
Immunology · 61d
Cleared Jul 21, 1987
EYE GARD
K872000 · HOY
Treace Medical, Inc.
Ophthalmic · 56d
Cleared Jul 21, 1987
BI-ARTICULAR II HIP DEVICE
K872019 · KWY
Zimmer, Inc.
Orthopedic · 56d
Cleared Jul 21, 1987
WASHING/INJECTION NEEDLE
K872060 · FBK
Endovations
Gastroenterology & Urology · 54d
Cleared Jul 21, 1987
INNOFLUOR PHENYTOIN CALIBRATOR SET
K872142 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
K872156 · HWC
Concept, Inc.
Orthopedic · 47d
Cleared Jul 21, 1987
DIDECO-SHILEY WASTE COLLECTION BAG
K872158 · CAC
Shiley, Inc.
Anesthesiology · 47d
Cleared Jul 21, 1987
DIDECO-SHILEY BLOOD REINFUSION BAG
K872162 · CAC
Shiley, Inc.
Anesthesiology · 47d
Cleared Jul 21, 1987
ETHANOL CALIBRATOR
K872181 · DLJ
American Monitor Corp.
Toxicology · 43d
Cleared Jul 21, 1987
AMBULATORY EEG PLAYBACK
K872183 · GWQ
Cadwell Laboratories, Inc.
Neurology · 43d
Cleared Jul 21, 1987
CORD-ASSURE UMBILICAL BLOOD GAS KIT
K872244 · CBT
Lake Medical Products, Inc.
Anesthesiology · 40d
Cleared Jul 21, 1987
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · DSH
Medtronic Vascular
Cardiovascular · 40d
Cleared Jul 21, 1987
SIRECUST MODEL 960 AND 961 PATIENT MONITORING
K872249 · DRT
Medical Electronics Laboratories, Inc.
Cardiovascular · 39d
Cleared Jul 21, 1987
ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP
K872270 · HRX
Orthoconcept, Inc.
Orthopedic · 39d
Cleared Jul 21, 1987
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
K872277 · CBH
Ackrad Laboratories
Anesthesiology · 36d
Cleared Jul 21, 1987
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jul 21, 1987
INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET
K872349 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Jul 21, 1987
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354 · DRT
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
K872397 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 29d