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
75817–75840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2002
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
K020725 · FLL
Microlife Corp.
General Hospital · 6d
Cleared Mar 11, 2002
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · HSD
Corin USA
Orthopedic · 228d
Cleared Mar 11, 2002
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX,...
K012869 · HIH
Gimmi GmbH
Obstetrics & Gynecology · 196d
Cleared Mar 11, 2002
VISTITOME 20-10 MICROKERATOME
K014000 · HNO
Biovision AG
Ophthalmic · 97d
Cleared Mar 11, 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090 · KWP
Endius, Inc.
Orthopedic · 90d
Cleared Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960 · MXZ
Biogenex Laboratories
Pathology · 185d
Cleared Mar 08, 2002
ACT 11 MP VENTRICULAR CATHETER
K013005 · HCA
Innerspace, Inc.
Neurology · 183d
Cleared Mar 08, 2002
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES...
K013267 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 158d
Cleared Mar 08, 2002
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
K013318 · KFF
American Diagnostica, Inc.
Hematology · 154d
Cleared Mar 08, 2002
LP(A)-LATEX SEIKEN ASSAY KIT
K013359 · DFC
Denka Seiken'S
Chemistry · 149d
Cleared Mar 08, 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · JHO
Quantimetrix Corp.
Chemistry · 122d
Cleared Mar 08, 2002
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K013677 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 121d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053 · MQV
Depuyacromed
Orthopedic · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · DQO
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 08, 2002
DERMASTAR ER:YAG LASER SYSTEM
K014057 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072 · KWY
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 88d
Cleared Mar 08, 2002
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · JEY
Stryker Instruments
Dental · 71d
Cleared Mar 08, 2002
SALUTE, MODEL 3022
K014286 · GDW
Onux Medical, Inc.
General & Plastic Surgery · 71d
Cleared Mar 08, 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN...
K020094 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL...
K020100 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
K020188 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 49d
Cleared Mar 08, 2002
SERRALENE, MODEL CATALOG NO 1S
K020265 · GAW
Serral, S.A. DE C.V.
General & Plastic Surgery · 42d
Cleared Mar 08, 2002
STERN MICRO ERA ATTACHMENT SYSTEM
K020391 · DZE
Sterngold
Dental · 30d