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
39505–39528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2013
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
K132522 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 126d
Cleared Dec 16, 2013
ONETOUCH REVEAL
K132618 · MRZ
Lifescan, Inc.
General Hospital · 117d
Cleared Dec 16, 2013
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL,...
K132688 · DIF
Biochemical Diagnostics, Inc.
Toxicology · 110d
Cleared Dec 16, 2013
STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
K132785 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 101d
Cleared Dec 16, 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 16, 2013
FUSIONSYNC, CHIMAERA FUSIONSYNC
K132963 · LLZ
Chimaera GmbH
Radiology · 87d
Cleared Dec 16, 2013
RHYTHM VIEW WORKSTATION
K133305 · DQK
Topera, Inc.
Cardiovascular · 49d
Cleared Dec 16, 2013
SONOSITE EDGE ULTRASOUND SYSTEM
K133454 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Dec 13, 2013
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET...
K121248 · JXG
Moller Medical GmbH
Neurology · 597d
Cleared Dec 13, 2013
HEPAFAT SCAN
K122035 · LNH
Resonance Health Analysis Services...
Radiology · 520d
Cleared Dec 13, 2013
MICRODOSE SI
K130704 · MUE
Philips Digital Mammography Sweden AB
Radiology · 273d
Cleared Dec 13, 2013
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
K130738 · GDW
Nanjing Maidixin Medical Device Co.,...
General & Plastic Surgery · 270d
Cleared Dec 13, 2013
GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
K130913 · MAX
Genesys Spine
Orthopedic · 255d
Cleared Dec 13, 2013
PROVANT THERAPY SYSTEM
K131979 · ILX
Regenesis Biomedical, Inc.
Physical Medicine · 168d
Cleared Dec 13, 2013
S-SCAN
K131996 · LNH
Esaote, S.P.A.
Radiology · 168d
Cleared Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 165d
Cleared Dec 13, 2013
DURABLUE STERILIZATION WRAP
K132060 · FRG
Cardinal Health-Medical Products and...
General Hospital · 163d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Dec 13, 2013
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K132484 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 127d
Cleared Dec 13, 2013
CROSSCHECK PLATING SYSTEM
K132594 · HRS
Solana Surgical, LLC
Orthopedic · 116d
Cleared Dec 13, 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 77d
Cleared Dec 12, 2013
AIDI DENTAL IMPLANT SYSTEM
K123861 · DZE
Aidi Biomedical, LLC
Dental · 363d
Cleared Dec 12, 2013
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
K130439 · DRN
Chongqing Psk Sci-Tech Development...
Cardiovascular · 294d
Cleared Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
K131766 · JAA
Apelem-Dms Group
Radiology · 178d