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
64849–64872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2005
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 15, 2005
VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221
K051857 · CCK
Weissburg Associates
Anesthesiology · 69d
Cleared Sep 15, 2005
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K051997 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 52d
Cleared Sep 15, 2005
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K052382 · LZA
Pt.Shamrock Manufacturing Corp.
General Hospital · 16d
Cleared Sep 15, 2005
CORONIS 2MP-21 AND MFGD 2621
K052403 · LLZ
Barcoview
Radiology · 14d
Cleared Sep 15, 2005
CORONIS 3MP-21 AND MFGD 3621
K052429 · LLZ
Barcoview
Radiology · 9d
Cleared Sep 14, 2005
OSTEOPAL V
K050085 · LOD
Heraeus Kulzer,GmbH
Orthopedic · 244d
Cleared Sep 14, 2005
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
K050382 · GEX
Cynosure, Inc.
General & Plastic Surgery · 211d
Cleared Sep 14, 2005
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
K050524 · IRQ
Marda Medical, Inc.
Physical Medicine · 196d
Cleared Sep 14, 2005
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · LPN
Alcon Research, Ltd.
Ophthalmic · 177d
Cleared Sep 14, 2005
PICONIBP OEM MODULE
K051366 · DXN
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 112d
Cleared Sep 14, 2005
SINGLE AMPLIFIER FOR BOTOX
K051852 · GWL
Allergan, Inc.
Neurology · 68d
Cleared Sep 14, 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · ILY
Cynosure, Inc.
Physical Medicine · 61d
Cleared Sep 14, 2005
ENDO-EASE ENDOSCOPIC OVERTUBE
K052084 · FED
Spirus Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 14, 2005
DUREPAIR DURA REGENERATION MATRIX
K052211 · GXQ
Medtronic Neurosurgery
Neurology · 30d
Cleared Sep 14, 2005
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
K052247 · KWP
Abbott Spine, Inc.
Orthopedic · 27d
Cleared Sep 14, 2005
DORSAL NAIL PLATE, ANATOMICAL
K052248 · HRS
Hand Innovations, LLC
Orthopedic · 27d
Cleared Sep 14, 2005
POLARIS LV, LVA APPLICATOR
K052324 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 20d
Cleared Sep 14, 2005
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325 · MUJ
Accuray Incorporated
Radiology · 20d
Cleared Sep 14, 2005
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C
K052344 · LLZ
Eizo Nanao Corporation
Radiology · 19d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Ge Healthcare
Radiology · 19d
Cleared Sep 14, 2005
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
K052355 · IYO
U-Systems, Inc.
Radiology · 16d
Cleared Sep 14, 2005
THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
K052454 · NTE
Abbott Vascular Devices
Cardiovascular · 8d
Cleared Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · LZG
Roche Diagnostics Corp.
General Hospital · 173d