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
43609–43632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2012
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K113783 · LON
bioMerieux, Inc.
Microbiology · 229d
Cleared Aug 07, 2012
SUCTION LIPOLASTY ACCESSORIES
K113795 · QPB
Norman M. Black Iii
General & Plastic Surgery · 228d
Cleared Aug 07, 2012
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · MDB
Becton, Dickinson and Company
Microbiology · 127d
Cleared Aug 07, 2012
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
K121059 · IMG
Zimmer Medizinsystems GmbH
Physical Medicine · 123d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
K122141 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 19d
Cleared Aug 06, 2012
ET II BIO-SA FIXTURE SYSTEM
K112532 · DZE
Hiossen, Inc.
Dental · 341d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
K113437 · LCP
Alfa Wassermann Diagnostic...
Chemistry · 259d
Cleared Aug 06, 2012
HEART SYNC PEDIATRIC PHYSIO AED PAD
K120536 · MKJ
Heart Sync, Inc.
Cardiovascular · 166d
Cleared Aug 06, 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · NLH
Sterilmed, Inc.
Cardiovascular · 112d
Cleared CT Aug 06, 2012
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
K121698 · EJR
Dentsply International, Inc.
Dental · 59d
Cleared Aug 06, 2012
G-SCAN BRIO
K122006 · LNH
Esaote, S.P.A.
Radiology · 28d
Cleared Aug 03, 2012
IDENTIFY
K112692 · IYE
Humediq GmbH
Radiology · 323d
Cleared Aug 03, 2012
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
K113077 · NBW
Taidoc Technology Corporation
Chemistry · 291d
Cleared Aug 03, 2012
MASTERKA 40 MASTERKA 35 MASTERKA 30
K113536 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 247d
Cleared Aug 03, 2012
MYSAFETY SYRINGE
K113673 · FMF
Medicalchain Internartional Corporation
General Hospital · 234d
Cleared Aug 03, 2012
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
K120423 · NBW
Bionime Corporation
Chemistry · 172d
Cleared Aug 03, 2012
8MP COLOR LCD MONITOR, REDIFORCE RX840
K120451 · LLZ
Eizo Nanao Corporation
Radiology · 171d
Cleared Aug 03, 2012
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT...
K120898 · OTJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 130d
Cleared CT Aug 03, 2012
TREVO RETRIEVER
K120961 · NRY
Concentric Medical, Inc.
Neurology · 126d
Cleared Aug 03, 2012
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · JCT
Boston Scientific Corp
General & Plastic Surgery · 119d
Cleared Aug 03, 2012
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
K121192 · LZA
Tekmedic (M) Sdn Bhd
General Hospital · 106d
Cleared Aug 03, 2012
LTM-LABAROSCOPIC SURGICAL MESH
K121289 · OXK
Lifecell Corp.
General & Plastic Surgery · 95d
Cleared Aug 03, 2012
UROPLASTY RIGID ENDOSCPIC NEEDLES
K121337 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 92d