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
124681–124704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1990
METRICARE EMPTY CONTAINER SYSTEMS
K895922 · LHI
Metrix Co.
General Hospital · 315d
Cleared Aug 22, 1990
MULTI DOPPLEX, MD-1
K900882 · JAF
Huntleigh Technology, Inc.
Radiology · 177d
Cleared Aug 22, 1990
MER MULTIPLANE RECTAL PROBE (MRP)
K901033 · IYO
Medical Equipment Resources
Radiology · 169d
Cleared Aug 22, 1990
MER MULTIPLANE VAGINAL PROBE (MVP)
K901142 · HGL
Medical Equipment Resources
Obstetrics & Gynecology · 163d
Cleared Aug 22, 1990
NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM
K901263 · FOZ
Navion Biomedical Corp.
General Hospital · 159d
Cleared Aug 22, 1990
MODIFIED FREEMAN ACETABULAR CUP
K902110 · KWA
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Aug 22, 1990
MODIFIED FREEMAN REVISION ACETABULAR CUP
K902111 · KWA
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · JIR
Stanbio Laboratory
Chemistry · 98d
Cleared Aug 22, 1990
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS
K902298 · BSJ
Rondex Products, Inc.
Anesthesiology · 92d
Cleared Aug 22, 1990
ULTRA-VU ANGIOSCOPE
K902329 · LYK
Angiolaz, Inc.
Cardiovascular · 90d
Cleared Aug 22, 1990
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
K902335 · JWH
Intermedics Orthopedics
Orthopedic · 90d
Cleared Aug 22, 1990
TRI-COUNT 16
K902389 · JCN
Hematronix, Inc.
Hematology · 84d
Cleared Aug 22, 1990
CELL-DYN 3000 CONTROL
K902391 · JCN
Unipath , Ltd.
Hematology · 84d
Cleared Aug 22, 1990
LYMPHO SEP(TM)
K902445 · JCF
Icn Biomedicals, Inc.
Hematology · 82d
Cleared Aug 22, 1990
FLORA-STAT URINE TRANSPORT SYSTEM
K902467 · LIO
Wadley Biosciences Corp.
Microbiology · 79d
Cleared Aug 22, 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · GGT
Incstar Corp.
Hematology · 69d
Cleared Aug 22, 1990
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K902733 · BTM
Intertech Resources, Inc.
Anesthesiology · 62d
Cleared Aug 22, 1990
PR CANNULAS
K902734 · FGE
Olympus Corp.
Gastroenterology & Urology · 62d
Cleared Aug 22, 1990
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL
K902909 · JJY
Creative Laboratory Products, Inc.
Chemistry · 50d
Cleared Aug 22, 1990
IL PHENYTOIN ASSAY SYSTEM
K902952 · DIP
Instrumentation Laboratory CO
Toxicology · 48d
Cleared Aug 22, 1990
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101 · DLJ
Innotron of Oregon, Inc.
Toxicology · 40d
Cleared Aug 22, 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · DIF
Eastman Kodak Company
Chemistry · 34d
Cleared Aug 22, 1990
IL TOBRAMYCIN ASSAY
K903192 · KLB
Instrumentation Laboratory CO
Chemistry · 34d
Cleared Aug 22, 1990
REDITEST STREP A TEST KIT
K903194 · GTZ
Boehringer Mannheim Corp.
Microbiology · 34d