Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82465–82488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d
Cleared Jul 31, 2000
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
K001690 · FMI
Johnson & Johnson Medical, Inc.
General Hospital · 59d
Cleared Jul 31, 2000
DC TITAN
K001798 · EJH
Austenal, Inc.
Dental · 47d
Cleared Jul 31, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH...
K002175 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH...
K002176 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
ADVANCED UROSCIENCE INJECTION NEEDLE
K002323 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 34d
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