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
102673–102696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1995
4000 AU ULTRASOUND IMAGING SYSTEM
K944485 · IYO
Biosound, Inc.
Radiology · 253d
Cleared May 24, 1995
AIRIS
K945155 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 215d
Cleared May 24, 1995
MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
K945413 · MAJ
Medtronic Vascular
General Hospital · 202d
Cleared May 24, 1995
COLTOLUX 3, COLTOLUX 4
K945698 · EBZ
Coltene/Whaledent, Inc.
Dental · 188d
Cleared May 24, 1995
IM512P
K945792 · IYX
Globus Industries
Radiology · 180d
Cleared May 24, 1995
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM
K945796 · ITX
Sharplan Lasers, Inc.
Radiology · 177d
Cleared May 24, 1995
FLUOREX DTA-400A
K946081 · JAA
Toshiba America Medical Systems, In.C
Radiology · 162d
Cleared May 24, 1995
COLTOLUX LIGHT METER
K950106 · EBZ
Coltene/Whaledent, Inc.
Dental · 133d
Cleared May 24, 1995
EXPERT MORPHOMERTY SOFTWARD
K950611 · KGI
Lunar Corp.
Radiology · 103d
Cleared May 24, 1995
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
K950687 · DSP
Belmont Instrument Corp.
Cardiovascular · 99d
Cleared May 24, 1995
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared May 24, 1995
SUNBLOCKER SUNGLASSES
K950807 · HQY
Blublocker Corp.
Ophthalmic · 91d
Cleared May 24, 1995
KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR...
K950862 · GCJ
Karl Storz Imaging, Inc.
General & Plastic Surgery · 86d
Cleared May 24, 1995
EARCLEAR
K951596 · MJV
Arisil Medical
Ear, Nose, Throat · 47d
Cleared May 24, 1995
NEZHAT-DORESEY PENCIL-GRIP HANDLES
K951732 · GEI
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 40d
Cleared May 24, 1995
STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM
K951875 · LJT
Strato/Infusaid, Inc.
General Hospital · 33d
Cleared May 24, 1995
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · IZH
Planmed OY
Radiology · 51d
Cleared May 24, 1995
ACCU-BEAM 300W XENON LIGHT SOURCE
K951895 · GCT
Tti Medical
Gastroenterology & Urology · 30d
Cleared May 24, 1995
XENON LIGHT SOURCE
K951971 · GCT
Envision Medical Corp.
Gastroenterology & Urology · 27d
Cleared May 24, 1995
KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR
K951995 · KNY
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 26d
Cleared May 23, 1995
THE STACHROM HEPARIN ASSAY KIT
K925433 · KFF
American Bioproducts Co.
Hematology · 937d
Cleared May 23, 1995
EXTENTION SET
K933524 · FPK
Mediziv Medical Products 1987 , Ltd.
General Hospital · 672d
Cleared May 23, 1995
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
K935842 · BTR
Rusch, Inc.
Anesthesiology · 532d
Cleared May 23, 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 496d