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
77353–77376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2001
TCM ENDO III
K013185 · EFA
NOUVAG AG
Dental · 65d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL...
K013199 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 64d
Cleared Nov 28, 2001
TOTAL O2
K013472 · CAW
Chad Therapeutics, Inc.
Anesthesiology · 41d
Cleared Nov 28, 2001
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
K013581 · DQY
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Nov 28, 2001
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
K013682 · DZE
Basic Dental Implant Systems, Inc.
Dental · 21d
Cleared Nov 28, 2001
SILMED NASAL SEPTAL BUTTON
K013696 · LFB
Silmed, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 2001
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K010771 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 258d
Cleared Nov 27, 2001
ORALLITE COMPREHENSIVE EXAM TRAY
K012070 · MPU
Trylon Corp.
Obstetrics & Gynecology · 148d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · KWP
Ebi, L.P.
Orthopedic · 113d
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