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
80713–80736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · FIP
Total Water Treatment Systems, Inc.
Gastroenterology & Urology · 226d
Cleared Feb 16, 2001
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90,...
K002054 · DYB
Appriva Medical, Inc.
Cardiovascular · 225d
Cleared Feb 16, 2001
ACTICOAT COMPOSITE DRESSING
K002466 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 189d
Cleared Feb 16, 2001
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
K002650 · FGE
Bentec Medical, Inc.
Gastroenterology & Urology · 175d
Cleared Feb 16, 2001
REGUTHERM 952 THERMOGRAPHIC SYSTEM
K003130 · LHQ
Sie-Med, Inc.
Radiology · 133d
Cleared Feb 16, 2001
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · FYA
Medline Industries, Inc.
General Hospital · 73d
Cleared Feb 16, 2001
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
K003932 · HQD
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933 · MUW
Polymer Technology
Ophthalmic · 58d
Cleared Feb 16, 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P,...
K010135 · INI
Invacare Corp.
Physical Medicine · 30d
Cleared Feb 16, 2001
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
K010297 · LZA
Maxxim Medical
General Hospital · 16d
Cleared Feb 16, 2001
ADVANTAGE WINDOWS CT/PET FUSION
K010336 · LLZ
Ge Medical Systems, Inc.
Radiology · 11d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · JWH
Howmedica Osteonics Corp.
Orthopedic · 311d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · MAI
Mitek Products
Orthopedic · 192d
Cleared Feb 15, 2001
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
K002596 · MLY
Gebauer Co.
Physical Medicine · 178d
Cleared Feb 15, 2001
PARIETEX COMPOSITE (PCO) MESH
K002699 · FTL
Medical Device Consultants, Inc.
General & Plastic Surgery · 169d
Cleared Feb 15, 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · JEY
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
ONYX-RAD TELEMEDICINE PACS
K003607 · LLZ
Viztek, Inc.
Radiology · 85d
Cleared Feb 15, 2001
PERMLASTIC 3
K003650 · ELW
Sybron Dental Specialties, Inc.
Dental · 80d
Cleared Feb 15, 2001
ACCUFUSER
K003915 · MEB
Help Technologies
General Hospital · 58d
Cleared Feb 15, 2001
NITRILE EXAMINATION GLOVES (POWERED)
K003922 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 57d
Cleared Feb 15, 2001
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D...
K003977 · FPA
Disetronic Medical Systems AG
General Hospital · 55d
Cleared Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
K004019 · LJM
The Binding Site, Ltd.
Immunology · 50d