FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122713–122736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1991
GLOBAL TOTAL SHOULDER
K905786 · KWT
Depuy, Inc.
Orthopedic · 89d
Cleared Mar 26, 1991
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
K910019 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 82d
Cleared Mar 26, 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 26, 1991
PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
K910755 · MEH
Intermedics Orthopedics
Orthopedic · 39d
Cleared Mar 26, 1991
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
K910988 · JDI
Osteonics Corp.
Orthopedic · 19d
Cleared Mar 26, 1991
QUAD-LINK RETRACTABLE MOUNT
K911152 · ITI
Tarsys Engineering, Inc.
Physical Medicine · 11d
Cleared Mar 25, 1991
OWENS CATHETER
K896520 · LIT
Boston Scientific Corp
Cardiovascular · 495d
Cleared Mar 25, 1991
DYNAMIC SPECTRAL PHONOCARDIOGRAPH
K902185 · DQC
Reeves Scientific, Inc.
Cardiovascular · 315d
Cleared Mar 25, 1991
DIAGNOSTIC INTRASCULAR CATHETER
K903848 · DQO
Applied Vascular Devices, Inc.
Cardiovascular · 216d
Cleared Mar 25, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 180d
Cleared Mar 25, 1991
ES/ULTRA DISPLAY AND PROCESSING STATION
K905412 · IYX
Toshiba America Medical Systems, In.C
Radiology · 112d
Cleared Mar 25, 1991
VESSEL DILATOR
K905416 · DRE
The R Group
Cardiovascular · 111d
Cleared Mar 25, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
K910220 · LNH
Toshiba America Mri, Inc.
Radiology · 67d
Cleared Mar 25, 1991
MAGNETOM 42 SP AND 63 SP
K910498 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Mar 22, 1991
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
K900105 · LKN
Cobe Laboratories, Inc.
Gastroenterology & Urology · 437d
Cleared Mar 22, 1991
NATURE'S CRADLE(TM)
K901763 · FMS
Infant Advantage, Inc.
General Hospital · 338d
Cleared Mar 22, 1991
QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM
K904019 · IYO
Quantum Medical Systems, Inc.
Radiology · 204d
Cleared Mar 22, 1991
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER
K905054 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 134d
Cleared Mar 22, 1991
DAVID SIMMONDS ANESTHESIA EXTENSION TUBES
K905384 · FMF
Sparta Surgical Corp.
General Hospital · 113d
Cleared Mar 22, 1991
NEEDLESTICK PROTECTIVE GLOVE
K905527 · LZC
Medev Corp.
General Hospital · 102d
Cleared Mar 22, 1991
CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO
K905801 · LLZ
Cemax, Inc.
Radiology · 84d
Cleared Mar 22, 1991
PORTA GAS COMPRESSED GAS CYLINDER CART
K910071 · GET
Sen Tech Medical Corp.
General & Plastic Surgery · 72d
Cleared Mar 21, 1991
SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES
K904017 · IYN
Siemens Ultrasound, Inc.
Radiology · 203d
Cleared Mar 21, 1991
STETHOSCOPE
K904547 · LDE
Kimball Industries Co., Ltd.
Cardiovascular · 169d