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

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175,820 results
37777–37800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 30, 2014
DUAL SHOT ALPHA 7
K133189 · DXT
Nemoto Kyorindo Co., Ltd.
Cardiovascular · 256d
Cleared Jun 30, 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION...
K133575 · MNH
Spinevision S.A.
Orthopedic · 222d
Cleared Jun 30, 2014
SHUNTONG
K140243 · LYZ
Shuntong Glove Co., Ltd.
General Hospital · 151d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · LZO
Exactech, Inc.
Orthopedic · 104d
Cleared Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 97d
Cleared Jun 30, 2014
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · JWH
Conformis, Inc.
Orthopedic · 89d
Cleared Jun 30, 2014
MBD PLATE SYSTEM
K141045 · HRS
Mbd Medical, LLC
Orthopedic · 68d
Cleared Jun 30, 2014
BICARBONATE CALIBRATOR
K141374 · JIT
Beckman Coulter Ireland, Inc.
Chemistry · 34d
Cleared Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
K141395 · LPH
Lima Corporate S.P.A.
Orthopedic · 33d
Cleared Jun 30, 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · HSB
Ellipse Technologies, Inc.
Orthopedic · 28d