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
55873–55896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2008
SUNIVF DISHES
K080395 · MQK
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Aug 13, 2008
TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
K080710 · NBW
Home Diagnostics, Inc.
Chemistry · 153d
Cleared Aug 13, 2008
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND...
K081086 · BTR
Smiths Medical Asd, Inc.
Anesthesiology · 119d
Cleared Aug 13, 2008
PARIETEX COMPOSITE MONO PM MESH
K081126 · FTL
Sofradim Production
General & Plastic Surgery · 114d
Cleared Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342 · KTT
Sterilmed, Inc.
Orthopedic · 92d
Cleared Aug 13, 2008
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
K081459 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 82d
Cleared Aug 13, 2008
AVEA VENTILATOR
K081837 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 44d
Cleared Aug 13, 2008
SOLEX CATHETER, MODEL SL2593
K081936 · NCX
Alsius Corp.
Neurology · 37d
Cleared Aug 13, 2008
BODY-JET
K082025 · QPB
Human Med AG
General & Plastic Surgery · 27d
Cleared Aug 13, 2008
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
K082175 · GXN
Bioplate, Inc.
Neurology · 12d
Cleared Aug 13, 2008
SERIES SY DISPOSABLE ELECTROSURGICAL PAD
K082204 · ODR
Ventlab Corp.
General & Plastic Surgery · 8d
Cleared Aug 13, 2008
MAX ADJUSTING INSTRUMENT
K082218 · LXM
Manna Omni International, Inc.
Physical Medicine · 7d
Cleared Aug 12, 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · DQX
Stereotaxis, Inc.
Cardiovascular · 159d
Cleared Aug 12, 2008
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
K080926 · CAF
Trudell Medical Intl.
Anesthesiology · 132d
Cleared Aug 12, 2008
BIOACTIF OSTEOTRANS INTERFENCE SCREW
K081390 · HWC
Takiron Co., Ltd.
Orthopedic · 85d
Cleared Aug 12, 2008
ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS
K081647 · GEI
Xodus Medical, Inc.
General & Plastic Surgery · 61d
Cleared Aug 12, 2008
DMC COMPOSITE
K081695 · EBF
Kerr Corp.
Dental · 56d
Cleared Aug 12, 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL...
K081745 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939 · GEX
Omniguide, Inc.
General & Plastic Surgery · 35d
Cleared Aug 12, 2008
NEUROCATH AG
K081942 · JXG
Vygon Neuro
Neurology · 35d
Cleared Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Aug 11, 2008
WEBERNEEDLE BASIC LASER
K073352 · ILY
Weber Medical GmbH
Physical Medicine · 256d
Cleared Aug 11, 2008
FINDRWIRZ GUIDE WIRE SYSTEM
K080364 · DQX
Sentreheart, Inc.
Cardiovascular · 182d
Cleared Aug 11, 2008
WINCO MODEL POWER SERIES LIFT CHAIR
K080533 · INO
Winco, Inc.
Physical Medicine · 167d