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
38521–38544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2014
WUNDER PREGNANCY TEST
K130456 · JHI
James Nguyen
Chemistry · 410d
Cleared Apr 08, 2014
ULTRAFUSE
K130531 · MQV
Baxter Healthcare Corp
Orthopedic · 403d
Cleared Apr 08, 2014
THE GYNOCULAR
K132423 · HEX
Gynius AB
Obstetrics & Gynecology · 246d
Cleared Apr 08, 2014
ORTHROS POSTERIOR STABILIZATION SYSTEM
K133366 · NKB
Camber Spine
Orthopedic · 158d
Cleared Apr 08, 2014
SURGICAL LIGHT HANDLE COVER
K133554 · FTA
Microtek Medical, Inc. an Ecolab Company
General & Plastic Surgery · 140d
Cleared Apr 08, 2014
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE...
K133949 · LZA
Top Calibre Sdn Bhd
General Hospital · 106d
Cleared Apr 08, 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 84d
Cleared Apr 08, 2014
MANDREL GUIDEWIRE
K140482 · OCY
Lake Region Medical
Gastroenterology & Urology · 41d
Cleared Apr 07, 2014
SYNGO DUAL ENERGY SOFTWARE PACKAGE
K132902 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 203d
Cleared Apr 07, 2014
HYDROPHILIC COATED GUIDEWIRE
K133155 · DQX
Lake Region Medical
Cardiovascular · 172d
Cleared Apr 07, 2014
THREADED PEEK K-WIRE
K133235 · MBI
Mtp Solutions, LLC
Orthopedic · 168d
Cleared Apr 07, 2014
BAXANO SURGICAL MIS SPINAL SYSTEM
K133743 · NKB
Baxano Surgical, Inc.
Orthopedic · 119d
Cleared Apr 07, 2014
SPEED TRIAD
K133844 · JDR
Biomedical Ent., Inc.
Orthopedic · 110d
Cleared Apr 07, 2014
ABACUS TM SPACER SYSTEM
K140007 · MAX
Spine Wave, Inc.
Orthopedic · 95d
Cleared Apr 07, 2014
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS...
K140069 · HRS
Merete Medical GmbH
Orthopedic · 84d
Cleared Apr 07, 2014
FRAGMENT PLATE SYSTEM
K140372 · HRS
Skeletal Dynamics, LLC
Orthopedic · 52d
Cleared Apr 04, 2014
A1C GEAR SYSTEM
K130014 · LCP
Sakae Corporation
Chemistry · 457d
Cleared Apr 04, 2014
CLOUDEKG
K130878 · DXH
Makromed, Inc.
Cardiovascular · 371d
Cleared Apr 04, 2014
AFTAMED MOUTHWASH
K130959 · OLR
Bioplax Limited
General & Plastic Surgery · 364d
Cleared Apr 04, 2014
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
K132381 · LNH
Clearmri Solutions, Inc.
Radiology · 247d
Cleared Apr 04, 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911 · HWC
In2bones Sas
Orthopedic · 199d
Cleared Apr 04, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377 · NHA
Nobel Biocare AB
Dental · 151d
Cleared Apr 04, 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 143d
Cleared Apr 04, 2014
ARIA RADIATION THERAPY MANAGEMENT
K133572 · IYE
Varian Medical Systems, Inc.
Radiology · 135d