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
80233–80256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS...
K010784 · MUJ
Nucletron Corp.
Radiology · 26d
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC
Corgenix, Inc.
Immunology · 346d
Cleared Apr 09, 2001
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
K002902 · MSD
The Kendall Company
Gastroenterology & Urology · 203d
Cleared Apr 09, 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL...
K002981 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 196d
Cleared Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · LYC
Biomet, Inc.
Dental · 147d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Synthes (Usa)
Orthopedic · 144d
Cleared Apr 09, 2001
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
K003676 · GEI
Rita Medical Systems
General & Plastic Surgery · 131d