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
48481–48504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2011
ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
K103533 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 49d
Cleared Jan 19, 2011
WBR XPRESS PET
K103710 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared Jan 18, 2011
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
K083894 · MAX
4-Web Spine, LLC
Orthopedic · 750d
Cleared Jan 18, 2011
IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
K093627 · ONF
Shanghai Apolo Medical Technologies...
General & Plastic Surgery · 421d
Cleared Jan 18, 2011
RVT CTO DEVICE
K101599 · PDU
Revascular Therapeutics, Inc.
Cardiovascular · 225d
Cleared Jan 18, 2011
NEXGEN PERIPHERAL GUIDE CATHETER
K102979 · DQY
Nexgen Medical Systems, Inc.
Cardiovascular · 104d
Cleared Jan 18, 2011
VEPER SYSTEM, EXPEDIUM SYSTEM
K103133 · NKB
Depuy Spine, Inc.
Orthopedic · 85d
Cleared Jan 18, 2011
CARDIO MED
K103334 · LDD
Cardio Medical Products, Inc.
Cardiovascular · 64d
Cleared Jan 18, 2011
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
K103469 · KRL
Sorin Group Deutschland GmbH
Cardiovascular · 55d
Cleared Jan 14, 2011
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
K092963 · MQL
Intl., Inc.
Obstetrics & Gynecology · 476d
Cleared Jan 14, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS
K100649 · LXB
Sonitus Medical, Inc.
Ear, Nose, Throat · 312d
Cleared Jan 14, 2011
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA...
K100829 · JGS
Medica Corp.
Chemistry · 296d
Cleared Jan 14, 2011
AUDIT MICROCV PROTEIN LINEARITY SET
K101216 · JJY
Aalto Scientific, Ltd.
Chemistry · 259d
Cleared Jan 14, 2011
E1 AVANTAGE HEAD
K101336 · LPH
Biomet Manufacturing Corp
Orthopedic · 247d
Cleared Jan 14, 2011
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K102077 · GWM
Cma Microdialysis AB
Neurology · 175d
Cleared Jan 14, 2011
NORFOLK MEDICAL NORPORT FAMILY OF PORTS
K102385 · LJT
Norfolk Medical Products, Inc.
General Hospital · 144d
Cleared Jan 14, 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY...
K102432 · MRG
Diazyme Laboratories
Chemistry · 141d
Cleared Jan 14, 2011
IMC HYPODERMIC NEEDLE
K102584 · FMI
International Medsurg Connection
General Hospital · 128d
Cleared Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
K102589 · JXG
Codman & Shurtleff, Inc.
Neurology · 127d
Cleared Jan 14, 2011
ORTHOFLEX ROD
K102601 · KWH
Ortho-Pro, LLC
Orthopedic · 127d
Cleared Jan 14, 2011
AHWON'S IPL SYSTEM
K102857 · ONF
Ahwon Medi Instrument Co., Ltd.
General & Plastic Surgery · 107d
Cleared Jan 14, 2011
84E SERIES SINGLE PLY WRAPPER
K102864 · FRG
Lac Mac, Ltd.
General Hospital · 106d
Cleared Jan 14, 2011
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010,...
K102885 · JEC
Stryker Corp.
Orthopedic · 106d
Cleared Jan 14, 2011
INFRARED EAR THERMOMETER, MODEL IR-04MT
K102934 · FLL
Vega Technologies, Inc.
General Hospital · 102d