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
76321–76344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2002
SONOPSY
K013109 · FCG
Hakko Medical Co., Ltd.
Gastroenterology & Urology · 176d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · MMX
Boston Scientific, Target
Cardiovascular · 88d
Cleared Mar 12, 2002
GREAT TOE IMPLANT SYSTEM
K014164 · KWD
Harmos Orthopaedics, Inc.
Orthopedic · 83d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · MRW
Nuvasive, Inc.
Orthopedic · 33d
Cleared Mar 12, 2002
RBM
K020480 · KGS
Smith & Nephew, Inc.
General & Plastic Surgery · 27d
Cleared Mar 12, 2002
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · KPE
Baxter Healthcare Corp
General Hospital · 27d
Cleared Mar 12, 2002
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES
K020544 · FPA
Churchill Medical Systems, Inc.
General Hospital · 25d
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