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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71401–71424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 376d
Cleared Sep 29, 2003
AML HAIRCHECK-DT (COCAINE)
K023626 · DIO
Quest Diagnostics, Inc.
Toxicology · 335d
Cleared Sep 29, 2003
DRESSSKIN
K023778 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 321d
Cleared Sep 29, 2003
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
K030003 · CIG
Elan Diagnostics
Chemistry · 270d
Cleared Sep 29, 2003
TORAYSULFONE DIALYZER, BS-L SERIES
K030050 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 266d
Cleared Sep 29, 2003
PARAPAC 200D TRANSPORT, MODEL V200D
K030803 · BTL
Pneupac , Ltd.
Anesthesiology · 200d
Cleared Sep 29, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
K031031 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 181d
Cleared Sep 29, 2003
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
K031225 · FTL
Gfe Medizintechnik GmbH
General & Plastic Surgery · 165d
Cleared Sep 29, 2003
INTRALASE FS LASER
K031960 · GEX
Intra Lase Corp.
General & Plastic Surgery · 96d
Cleared Sep 29, 2003
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00,...
K031974 · HIH
Asap Endoscopic Products GmbH
Obstetrics & Gynecology · 95d
Cleared Sep 29, 2003
ENVISION
K032042 · DYH
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · MID
The Binding Site, Ltd.
Immunology · 70d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE...
K032275 · LON
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 26, 2003
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
K024076 · LIF
Hdc Maquinolas, LLC
Gastroenterology & Urology · 290d
Cleared Sep 26, 2003
ATAC TOTAL BILIRUBIN REAGENT
K030014 · CIG
Elan Diagnostics
Chemistry · 267d
Cleared Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
K031308 · DBM
Rhigene, Inc.
Immunology · 155d
Cleared Sep 26, 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151 · JWH
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
K032342 · GKZ
Beckman Coulter, Inc.
Hematology · 59d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Sep 26, 2003
RAYCELL
K032684 · MOT
Mds Nordion
Radiology · 28d
Cleared Sep 26, 2003
DW 296 #15 SOLDER
K032715 · EJT
Ivoclar Vivadent, Inc.
Dental · 24d
Cleared Sep 26, 2003
IRRIGATION SETS
K032832 · HRX
Vital Concepts, Inc.
Orthopedic · 15d
Cleared Sep 26, 2003
CELON ENT SYSTEM
K032838 · GEI
Celon AG Medical Instruments
General & Plastic Surgery · 15d