FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81865–81888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378 · MAI
Bionx Implants, Inc.
Orthopedic · 88d
Cleared Jul 28, 2000
DATA MASTER PERFUSION MONITORING SYSTEM
K001388 · DRY
Dideco
Cardiovascular · 87d
Cleared Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 38d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP...
K002211 · FRN
Baxter Healthcare Corp
General Hospital · 7d
Cleared Jul 28, 2000
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161 · MAI
Synthes (Usa)
Orthopedic · 232d
Cleared Jul 27, 2000
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
K000050 · LYY
Top Quality Mfg., Inc.
General Hospital · 202d
Cleared Jul 27, 2000
CARDIOVISE ECG INTERPRETATIVE SOFTWARE
K001349 · MWJ
Inovise Medical, Inc.
Cardiovascular · 90d
Cleared Jul 27, 2000
E-Z LINK CROSS CONNECTOR
K001372 · KWP
Depuyacromed
Orthopedic · 87d
Cleared Jul 27, 2000
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
K001374 · KRR
Biomet Manufacturing, Inc.
Orthopedic · 87d
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · KWI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · HSD
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 27, 2000
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
K001527 · GEX
Fotona D.D.
General & Plastic Surgery · 72d
Cleared Jul 27, 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 71d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · FOZ
Abbott Laboratories
General Hospital · 63d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS...
K001739 · LYY
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 27, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · LWJ
Stelkast Company
Orthopedic · 49d
Cleared Jul 27, 2000
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001748 · LLZ
Barco NV Display Systems
Radiology · 49d
Cleared Jul 27, 2000
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001753 · LLZ
Barco NV Display Systems
Radiology · 49d
Cleared Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049 · LCX
Selfcare, Inc.
Chemistry · 24d
Cleared Jul 27, 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · JDI
Biomet, Inc.
Orthopedic · 15d
Cleared Jul 27, 2000
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · KGO
Ansell Perry
General Hospital · 7d
Cleared Jul 27, 2000
EPI-STAR SURGICAL LASER SYSTER
K990119 · GEX
Nidek, Inc.
General & Plastic Surgery · 561d
Cleared Jul 27, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · DIO
Alfa Scientific Designs, Inc.
Toxicology · 212d