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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
37177–37200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2014
LONGFIAN OXYGEN CONCENTRATOR
K131968 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 434d
Cleared Sep 05, 2014
AJAX DENTAL UNIT
K132245 · EIA
Pro Dental Services, LLC
Dental · 414d
Cleared Sep 05, 2014
SURESUBTRACTION LUNG
K133324 · JAK
Toshiba Medical Systems Corporation,...
Radiology · 311d
Cleared Sep 05, 2014
TRUSCULPT
K133739 · PBX
Cutera, Inc.
General & Plastic Surgery · 270d
Cleared Sep 05, 2014
DEKA SMARTXIDE LASER SYSTEM
K133895 · GEX
El.En S.P.A.
General & Plastic Surgery · 259d
Cleared Sep 05, 2014
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
K134025 · JAK
Toshibamedical Systems Corporation
Radiology · 249d
Cleared Sep 05, 2014
SOPIX INSIDE, SOPIX2 INSIDE
K140013 · MUH
Sopro - Acteon Group
Radiology · 246d
Cleared Sep 05, 2014
FORTICORE
K140280 · ODP
Nanovis, LLC
Orthopedic · 213d
Cleared Sep 05, 2014
TRUE BEAM, TRUE BEAM STX, EDGE
K140528 · IYE
Varian Medical Systems, Inc.
Radiology · 185d
Cleared Sep 05, 2014
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER...
K140911 · GKZ
Beckman Coulter, Inc.
Hematology · 149d
Cleared Sep 05, 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K141248 · MUJ
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Sep 05, 2014
AXXENT CERVICAL APPLICATOR
K141343 · JAD
Icad, Inc.
Radiology · 107d
Cleared Sep 05, 2014
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · KNW
Care Fusion
Gastroenterology & Urology · 86d
Cleared Sep 05, 2014
MSN-006
K141562 · EBG
GC America, Inc.
Dental · 85d
Cleared Sep 05, 2014
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K141572 · IYE
Impac Medical Systems, Inc.
Radiology · 85d
Cleared Sep 05, 2014
ARTIS ZEE/ZEEGO SW VC21
K141574 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Sep 05, 2014
MASTERGRAFT MATRIX EXT
K141824 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 60d
Cleared Sep 05, 2014
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE...
K142035 · NBW
Arkray Factory, Inc.
Chemistry · 39d
Cleared Sep 05, 2014
ELI 380 ELECTROCARDIOGRAPH
K142105 · DPS
Mortara Instrument, Inc.
Cardiovascular · 35d
Cleared Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 05, 2014
PALACOS R+G PRO
K142157 · LOD
Heraeus Medical GmbH
Orthopedic · 30d
Cleared Sep 04, 2014
QMASTER-H/REVO
K133797 · OAS
Telesystems Co., Ltd.
Radiology · 265d
Cleared Sep 04, 2014
PREMIUM
K133889 · FTL
Cousin Biotech Sas
General & Plastic Surgery · 258d
Cleared CT Sep 04, 2014
RHINIX NASAL FILTER
K134003 · NUP
Rhinix Aps
Ear, Nose, Throat · 251d