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

Filters: Cleared only ×
176,076 results
70345–70368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2004
REMEEX SYSTEM FOR URINARY INCONTINENCE
K033310 · OTN
Specialities Remeex International, S.L.
Gastroenterology & Urology · 93d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 15, 2004
UGYTEX MESH
K033376 · FTL
Sofradim Production
General & Plastic Surgery · 85d
Cleared Jan 15, 2004
SMALL BONE FIXATION SYSTEM
K033406 · HTY
Hand Innovations, Inc.
Orthopedic · 83d
Cleared Jan 15, 2004
REVOLIX LASER SYSTEMS
K033423 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 80d
Cleared Jan 15, 2004
LEXATITE QUICK ACRYLIC
K033432 · EBG
Imtec Corp.
Dental · 79d
Cleared Jan 15, 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · GZJ
Biomedical Life Systems, Inc.
Neurology · 77d
Cleared Jan 15, 2004
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 76d
Cleared Jan 15, 2004
TESCERA U-BAR AND BARRELS
K033472 · EBI
Bisco, Inc.
Dental · 73d
Cleared Jan 15, 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · DZE
KLS-Martin L.P.
Dental · 72d
Cleared Jan 15, 2004
EASI ECG ALGORITHM
K033513 · DRW
Philips Medical Systems
Cardiovascular · 70d
Cleared Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · HWC
Acumed, LLC
Orthopedic · 56d
Cleared Jan 15, 2004
FORCE FIBER
K033654 · GAT
Teleflex Medical
General & Plastic Surgery · 55d
Cleared Jan 15, 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · KOJ
Sirona Dental Systems GmbH
Dental · 52d
Cleared Jan 15, 2004
CONCEPT HP ADD-ON
K033773 · EBF
Ivoclar Vivadent, AG
Dental · 43d
Cleared Jan 15, 2004
MODIFICATION TO SERAQUEST VCA IGM
K033780 · LJN
Quest Intl., Inc.
Microbiology · 42d
Cleared Jan 15, 2004
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
K033815 · NPM
Geistlich-Pharma
Dental · 37d
Cleared Jan 15, 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 15, 2004
ARTHOSCOPY PUMP A115
K033927 · HRX
W.O.M. World of Medicine AG
Orthopedic · 28d
Cleared Jan 15, 2004
SOLAR 9500 INFORMATION MONITOR
K033964 · MHX
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Jan 15, 2004
GAMMA3 NAIL SYSTEM
K034002 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jan 15, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · FLL
Microlife Intellectual Property GmbH
General Hospital · 17d
Cleared Jan 15, 2004
MODIFICATION TO X-PORT DUO PORT
K034065 · LJT
C.R. Bard, Inc.
General Hospital · 17d
Cleared Jan 14, 2004
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
K030739 · FRN
Infusion Dynamics, Inc.
General Hospital · 310d