FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79609–79632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2001
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
K000592 · FPA
Myco Medical Supplies, Inc.
General Hospital · 415d
Cleared Apr 12, 2001
LASER MECHANISMS LASER SCANNING SYSTEM
K010113 · GEX
Laser Mechanisms, Inc.
General & Plastic Surgery · 86d
Cleared Apr 12, 2001
VISTAKON (METHAFILCON A) CONTACT LENSES
K010507 · LPL
Vistakon
Ophthalmic · 50d
Cleared Apr 12, 2001
RX HERCULINK PLUS BILIARY STENT SYSTEM
K010684 · FGE
Guidant Corp.
Gastroenterology & Urology · 35d
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Apr 12, 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · DQK
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · DPS
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2001
SIMPLICITY SILVER SET SOFT INFUSION
K010846 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Apr 12, 2001
R-SI-LINE METAL-BITE
K010926 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 16d
Cleared Apr 12, 2001
U04
K010942 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Apr 11, 2001
FIESTA IMAGING OPTION
K002997 · LNH
GE Medical Systems
Radiology · 197d
Cleared Apr 11, 2001
BIPOLAR TRIGGER-FLEX PROBE
K003126 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 188d
Cleared Apr 11, 2001
FUNET AMY MAMA BODY THERMOMETER
K003326 · FLL
Funai Radio & Communications Corp.
General Hospital · 169d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463 · MNH
Aesculap, Inc.
Orthopedic · 155d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104 · GEX
Candela Corp.
General & Plastic Surgery · 89d
Cleared Apr 11, 2001
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR...
K010114 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 85d
Cleared Apr 11, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
K010296 · LKF
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 70d
Cleared Apr 11, 2001
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
K010462 · FLL
Avita Corporation
General Hospital · 54d
Cleared Apr 11, 2001
VIGIL DNASE B CONTROL
K010693 · JJX
Beckman Coulter, Inc.
Immunology · 34d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Apr 11, 2001
ULNAR HEAD IMPLANT
K010786 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 11, 2001
CAPNOPROBE SL, MODEL 2000
K010795 · CCK
Optical Sensors, Inc.
Anesthesiology · 26d
Cleared Apr 11, 2001
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
K010821 · KXK
Medi-Physics Inc. Dba Nycomed...
Radiology · 23d