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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76849–76872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2001
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · KWQ
Depuy Acromed, Inc.
Orthopedic · 89d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · LZO
Apex Surgical, LLC
Orthopedic · 89d
Cleared Nov 27, 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20...
K013145 · CIT
Wiener Laboratories Saic
Chemistry · 68d
Cleared Nov 27, 2001
RUSCH POLYFLEX STENT KIT
K013266 · NYT
Rusch Intl.
General & Plastic Surgery · 57d
Cleared Nov 27, 2001
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
K013731 · EOQ
Gimmi GmbH
Ear, Nose, Throat · 18d
Cleared Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810 · MOS
W.L. Gore & Associates, Inc.
Radiology · 12d
Cleared Nov 26, 2001
COMPRESSIBLE LIMB SLEEVE
K011192 · JOW
Alliance Medical Corp.
Cardiovascular · 221d
Cleared Nov 26, 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · KWQ
Spine Vision, Inc.
Orthopedic · 90d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 26, 2001
ANEURYSM CLIPS
K013136 · HCH
Gistlstrasse
Neurology · 68d
Cleared Nov 26, 2001
RAPIDONE-ECSTASY TEST
K013180 · DJC
American Bio Medica Corp.
Toxicology · 63d
Cleared Nov 26, 2001
BACTI-SWAB DRY
K013711 · LIO
Remel Co.
Microbiology · 19d
Cleared Nov 26, 2001
LIVESURE METHADONE SCREEN TESTS
K013796 · DJR
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579 · DQY
Medtronic Vascular
Cardiovascular · 267d
Cleared Nov 21, 2001
RUSCH BRONCHUS BLOCKER KIT
K010596 · CBI
Rusch Intl.
Anesthesiology · 266d
Cleared Nov 21, 2001
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
K011328 · LOS
Bionet Company, Ltd.
Cardiovascular · 204d
Cleared Nov 21, 2001
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4
K011487 · DXZ
Somanetics Corp.
Cardiovascular · 190d
Cleared Nov 21, 2001
RENAL GUIDING SHEATH
K012854 · DYB
Terumo Medical Corp.
Cardiovascular · 89d
Cleared Nov 21, 2001
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
K012877 · EJT
Ivoclar USA, Inc.
Dental · 86d
Cleared Nov 21, 2001
CARTO XP EP NAVIGATION SYSTEM
K013083 · DQK
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · HWC
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 21, 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 21, 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · DPS
Cambridge Heart, Inc.
Cardiovascular · 26d
Cleared Nov 20, 2001
INFUSION IV SET
K001879 · LRS
Nirvi Intl. USA
General & Plastic Surgery · 518d