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
47881–47904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · OAS
VATECH Co., Ltd.
Radiology · 239d
Cleared Mar 25, 2011
THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230,...
K102275 · GEI
Thermedx, LLC
General & Plastic Surgery · 226d
Cleared Mar 25, 2011
APEX PS KNEE SYSTEM
K102578 · JWH
Omni Life Science, Inc.
Orthopedic · 198d
Cleared Mar 25, 2011
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
K102640 · EBI
Vertex-Dental B.V.
Dental · 192d
Cleared Mar 25, 2011
ORTHODONTIC SCREW
K103105 · OAT
Osstem Implant Co., Ltd.
Dental · 156d
Cleared Mar 25, 2011
LANX SPINAL SYSTEM
K103237 · NKB
Lanx, Inc.
Orthopedic · 143d
Cleared Mar 25, 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 127d
Cleared Mar 25, 2011
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE...
K103551 · FPA
Baxter Healthcare Corp
General Hospital · 113d
Cleared Mar 25, 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K110385 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 43d
Cleared Mar 25, 2011
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110526 · MKJ
ZOLL Medical Corporation
Cardiovascular · 29d
Cleared Mar 25, 2011
CAPTIVA SPINE FUSELOX CERVICAL CAGE
K110585 · ODP
Captiva Spine, Inc.
Orthopedic · 24d
Cleared Mar 25, 2011
LIGAMAX 5
K110699 · FZP
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 11d
Cleared Mar 24, 2011
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
K094035 · OQG
Stelkast Company
Orthopedic · 449d
Cleared Mar 24, 2011
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K101721 · BTO
Regulatory and Marketing Services, Inc.
Anesthesiology · 279d
Cleared Mar 24, 2011
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465 · MNS
Respironics, Inc.
Anesthesiology · 209d
Cleared Mar 24, 2011
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL...
K102647 · JGS
Elitechgroup Vital Scientific BV
Chemistry · 191d
Cleared Mar 24, 2011
BODYTOM NL 4000
K102677 · JAK
Neurologica Corporation
Radiology · 190d
Cleared Mar 24, 2011
GMK REVISION KNEE SC LINERS
K103170 · JWH
Medacta International S.A.
Orthopedic · 148d
Cleared Mar 24, 2011
PERFORMAX TOTAL FACE MASK
K103395 · BZD
Respironics, Inc.
Anesthesiology · 125d
Cleared Mar 24, 2011
MOBILEECG SYSTEM
K103427 · DPS
Memtec Corp.
Cardiovascular · 122d
Cleared Mar 24, 2011
THERMO SCIENTIFIC MAS R DOA TOTAL
K103656 · DIF
Microgenics Corporation
Toxicology · 99d
Cleared Mar 24, 2011
ZEST PETITE NASAL MASK
K103786 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 87d
Cleared Mar 24, 2011
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
K103837 · JWH
Ortho Development
Orthopedic · 84d
Cleared Mar 24, 2011
MANUKATEX
K110042 · FRO
Manuka Medical Limited
General & Plastic Surgery · 77d