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
46993–47016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2011
STAXXSD SYSTEM
K111469 · MQP
Spine Wave, Inc.
Orthopedic · 53d
Cleared Jul 19, 2011
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 19, 2011
MOBILEDIAGNOST WDR
K111725 · IZL
Sedecal., Sa.
Radiology · 29d
Cleared Jul 19, 2011
PLATEAU SPACER SYSTEM
K111835 · ODP
Life Spine, Inc.
Orthopedic · 20d
Cleared Jul 19, 2011
ABL90
K111897 · CHL
Radiometer Medical Aps
Chemistry · 14d
Cleared Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · MAX
Medtronic Sofamor Danek
Orthopedic · 208d
Cleared Jul 18, 2011
REPROCESSED ELECTROSURGICAL INSTRUMENT
K110189 · NUJ
Ascent Healthcare Solutions
General & Plastic Surgery · 175d
Cleared Jul 18, 2011
DOMAIN SURGICAL SYSTEM
K110439 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 153d
Cleared Jul 18, 2011
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
K110956 · FLL
Medivance, Inc.
General Hospital · 104d
Cleared Jul 18, 2011
REPROCESSED ENDOSCOPIC TROCARS
K111002 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 98d
Cleared Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
K111144 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Jul 15, 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND...
K093755 · NBW
Andon Medical Co., Ltd.
Chemistry · 585d
Cleared Jul 15, 2011
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
K102643 · KQP
Astoria-Pacific, Inc.
Chemistry · 304d
Cleared Jul 15, 2011
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA,...
K103685 · DQA
Beijing Rongrui-Century Scie. & Tech....
Anesthesiology · 210d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · MNI
Exactech, Inc.
Orthopedic · 172d
Cleared Jul 15, 2011
OPIATE ENZYME IMMUNOASSAY
K110298 · DJG
Lin-Zhi International, Inc.
Chemistry · 164d
Cleared Jul 15, 2011
ACG-8511 PORTABLE ECG MONITOR
K110328 · DPS
Andon Health Co, Ltd.
Cardiovascular · 162d
Cleared Jul 15, 2011
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
K110847 · KWS
Lima Corporate S.P.A.
Orthopedic · 109d
Cleared Jul 15, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K110857 · LYZ
Shandong Zhanpeng Medical Products...
General Hospital · 109d
Cleared Jul 15, 2011
BODY ANALYSIS SCALE, MODEL BG 17
K110928 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 102d
Cleared Jul 15, 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · IOR
Otto Bock Healthcare LP
Physical Medicine · 91d
Cleared Jul 15, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K111328 · LZA
Gx Corporation Sdn Bhd
General Hospital · 65d
Cleared Jul 15, 2011
FALCON
K111416 · JOP
Viasonix , Ltd.
Radiology · 56d
Cleared Jul 15, 2011
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K111417 · DYB
Access Scientific, Inc.
Cardiovascular · 56d