FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79105–79128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · DIO
Phamatech
Toxicology · 22d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · LAF
Phamatech
Toxicology · 22d
Cleared Apr 10, 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION...
K002000 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 284d
Cleared Apr 10, 2001
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
K003731 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 127d
Cleared Apr 10, 2001
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K010486 · LZA
Pt. Medisafe Technologies
General Hospital · 49d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 29d
Cleared Apr 10, 2001
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767 · LJT
Horizon Medical Products, Inc.
General Hospital · 27d
Cleared Apr 10, 2001
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
K010779 · FHO
Gibbons Surgical Corp.
Gastroenterology & Urology · 26d