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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37177–37200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2014
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
K141369 · IYN
Philips Ultrasound, Inc.
Radiology · 40d
Cleared Jul 02, 2014
SPHYGMOMANOMETER
K141392 · DXQ
Suzhou JJ Meter Co., Ltd.
Cardiovascular · 36d
Cleared Jul 02, 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · GWO
Jeil Medical Corporation
Neurology · 30d
Cleared Jul 02, 2014
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
K141485 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 27d
Cleared Jul 02, 2014
X-REPAIRSL
K141499 · FTL
Synthasome, Inc.
General & Plastic Surgery · 26d
Cleared Jul 02, 2014
AVREO INTERWORKS SYSTEM
K141556 · LLZ
Avreo, Inc.
Radiology · 20d
Cleared Jul 02, 2014
RS80A DIAGNOSTIC ULTRASOUND SYSTEM
K141620 · IYN
Samsung Medison Co., Ltd.
Radiology · 15d
Cleared Jul 01, 2014
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM,...
K132036 · MSX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 365d
Cleared Jul 01, 2014
DRE VENTURA
K132903 · BSZ
Dre Medical, Inc.
Anesthesiology · 288d
Cleared Jul 01, 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · KWP
K2m, Inc.
Orthopedic · 249d
Cleared Jul 01, 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
K133693 · MQB
Canon, Inc.
Radiology · 210d
Cleared Jul 01, 2014
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
K133916 · DQK
Biosense Webster, Inc.
Cardiovascular · 190d
Cleared Jul 01, 2014
MEGA BIG BOY CONDOM
K140379 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 137d
Cleared Jul 01, 2014
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
K140400 · ETN
Stryker Corporation
Ear, Nose, Throat · 133d
Cleared Jul 01, 2014
ALTERA SPACER
K140411 · MAX
Globus Medical, Inc.
Orthopedic · 133d
Cleared Jul 01, 2014
DESARA BLUE OV, DESARA BLUE SS
K140843 · OTN
Caldera Medical
Gastroenterology & Urology · 90d
Cleared Jul 01, 2014
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL...
K141148 · DRE
Cook Vascular, Inc.
Cardiovascular · 57d
Cleared Jul 01, 2014
ODISSEY TISSUE OXIMETER
K141234 · MUD
Vioptix, Inc.
Cardiovascular · 49d
Cleared Jul 01, 2014
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE...
K141406 · DJG
Immunalysis Corporation
Toxicology · 34d
Cleared Jul 01, 2014
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
K141458 · PGH
Focus Diagnostics
Microbiology · 29d
Cleared Jun 30, 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD...
K124021 · CGA
Arkray Factory, Inc.
Chemistry · 550d
Cleared Jun 30, 2014
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
K132354 · LZA
Advanced Health Products, Lot 60 & 61
General Hospital · 336d
Cleared Jun 30, 2014
MUELLER HINTON AGAR
K132491 · JTZ
Edge Biologicals, Inc.
Microbiology · 326d
Cleared Jun 30, 2014
ZF 720
K132551 · FSY
Umbel Corporation
General & Plastic Surgery · 320d