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
60745–60768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 26, 2006
HDR CT COMPATIBLE SPLIT RING APPLICATOR
K063382 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 48d
Cleared Dec 26, 2006
CRANEX NOVUS
K063459 · MUH
Soredex Palodex Group OY
Radiology · 41d
Cleared Dec 26, 2006
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · FMF
Terumo Medical Corp.
General Hospital · 21d
Cleared Dec 26, 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 20d
Cleared Dec 22, 2006
ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM
K060346 · NTB
Ultrazonix Dnt AB
General & Plastic Surgery · 315d
Cleared Dec 22, 2006
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV...
K060851 · LGZ
The Smithworks Company
General Hospital · 269d
Cleared Dec 22, 2006
LITHODIAMOND ULTRA
K061350 · LNS
Pck Electronic Industry & Trade Co.,...
Gastroenterology & Urology · 221d
Cleared Dec 22, 2006
INTERDRY TEXTILE WITH SILVER
K061615 · FRL
Milliken Chemical
General Hospital · 196d
Cleared Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · LIG
Inova Diagnostics, Inc.
Immunology · 176d
Cleared Dec 22, 2006
BOX PEEK VBR SYSTEM
K062151 · MQP
Innovasis, Inc.
Orthopedic · 148d
Cleared Dec 22, 2006
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1...
K062285 · JXM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 137d
Cleared Dec 22, 2006
HORUS LASER KERATOME
K062314 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 136d
Cleared Dec 22, 2006
APEX SPINE SYSTEM
K062513 · KWP
Spinecraft, Inc.
Orthopedic · 116d
Cleared Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · KGE
Olympus Medical Systems Corporation
Gastroenterology & Urology · 116d
Cleared Dec 22, 2006
BWII EEG DIGITAL, MODEL PV 1652
K062533 · OLT
Neurovirtual USA, Inc.
Neurology · 115d
Cleared Dec 22, 2006
AEQUALIS RESURFACING HEAD
K062661 · HSD
Tornier
Orthopedic · 106d
Cleared Dec 22, 2006
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 87d
Cleared Dec 22, 2006
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880 · GXZ
Ives Eeg Solutions, Inc.
Neurology · 87d
Cleared Dec 22, 2006
BONE INJECTION GUN (B.I.G.)
K062940 · FMI
Waismed, Ltd.
General Hospital · 85d
Cleared Dec 22, 2006
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN...
K062965 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 84d
Cleared Dec 22, 2006
OPUS HC482 DIRECT NASAL MASK
K063036 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 80d
Cleared Dec 22, 2006
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
K063057 · NQD
Diagnostic Products Corporation
Chemistry · 78d
Cleared Dec 22, 2006
HUMERUS LOCKING PLATING SYSTEM
K063095 · HRS
Newclip Technics
Orthopedic · 73d
Cleared Dec 22, 2006
LIFEPAK 20 DEFIBRILLATOR/ MONITOR
K063119 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 71d