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.

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

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175,820 results
147697–147720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1985
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
K852587 · OLT
Tracor Northern, Inc.
Neurology · 59d
Cleared Aug 16, 1985
CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR
K852744 · EBF
The S. S. White Co.
Dental · 50d
Cleared Aug 16, 1985
PORCELAIN VENEER SYSTEM BONDING KIT
K852745 · EBF
The S. S. White Co.
Dental · 50d
Cleared Aug 16, 1985
BAG DECANTER
K852777 · KPE
Advance Medical Designs, Inc.
General Hospital · 46d
Cleared Aug 16, 1985
BOTTLE DECANTER
K852778 · KPE
Advance Medical Designs, Inc.
General Hospital · 46d
Cleared Aug 16, 1985
VENTED SECONDARY IV ADMINISTRATION SET
K852881 · FPA
Lyphomed, Inc.
General Hospital · 38d
Cleared Aug 16, 1985
MAXIFILL TRANSFER SET
K852882 · LHI
Lyphomed, Inc.
General Hospital · 38d
Cleared Aug 16, 1985
PREFORMED TOOTH ARCH
K852981 · ELM
Swipes Dental Laboratory
Dental · 32d
Cleared Aug 16, 1985
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)
K853001 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 16, 1985
BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)
K853002 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 16, 1985
INTEGRITY
K853052 · EBG
Dentsply Intl.
Dental · 28d
Cleared Aug 16, 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · FMG
Icu Medical, Inc.
General Hospital · 11d
Cleared Aug 16, 1985
MULTICAP MULTIGAS CAPNOMETER PB252
K853396 · CCK
Instrumentarium Corp.
Anesthesiology · 4d
Cleared Aug 15, 1985
MONARCH STERILIZATION CONTAINER SYSTEM
K850289 · FRG
Monarch Products, Inc.
General Hospital · 203d
Cleared Aug 15, 1985
IRIDIUM SEEDS
K850382 · IWA
Radiation Safety & Nuclear Products,...
Radiology · 195d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM NA-30
K850804 · GEX
Xanar, Inc.
General & Plastic Surgery · 169d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM MODEL NA-40
K850805 · GEX
Xanar, Inc.
General & Plastic Surgery · 169d
Cleared Aug 15, 1985
CO 2 SURGICAL LASER SYSTEM NA-120
K850818 · GEX
Xanar, Inc.
General & Plastic Surgery · 168d
Cleared Aug 15, 1985
YSI MODEL 2372 TOTAL BLOOD LACTATE KIT
K852261 · KHP
Yellow Springs Instrument Co., Inc.
Chemistry · 83d
Cleared Aug 15, 1985
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · KWL
Biomet, Inc.
Orthopedic · 58d
Cleared Aug 15, 1985
THERMATIC SUCTION PUMP
K852646 · BTA
H.C.H. Products, Inc.
General & Plastic Surgery · 55d
Cleared Aug 15, 1985
EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN
K853296 · BYY
Parexel Intl. Corp.
General Hospital · 9d
Cleared Aug 15, 1985
HEALTHDYNE IMPLUSE VENTILATOR
K853300 · CBK
Healthdyne, Inc.
Anesthesiology · 9d
Cleared Aug 14, 1985
FEMTEST
K844173 · HES
Bionexus, Inc.
Obstetrics & Gynecology · 293d