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
60169–60192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063464 · MQP
Atlas Spine, Inc.
Orthopedic · 113d
Cleared Mar 09, 2007
ECONOLITH EM1000
K063504 · LNS
Medispec, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 09, 2007
REMSTAR AFLEX CPAP SYSTEM
K063830 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 73d
Cleared Mar 09, 2007
TCA 5R / 5S
K070123 · OWB
Dornier Medtech America, Inc.
Radiology · 52d
Cleared Mar 09, 2007
CARDIOCT
K070226 · LLZ
Shina Systems , Ltd.
Radiology · 44d
Cleared Mar 09, 2007
FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
K070275 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 39d
Cleared Mar 09, 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 09, 2007
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A
K070370 · LLZ
Totoku Electric Co., Ltd.
Radiology · 29d
Cleared Mar 09, 2007
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
K070378 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 29d
Cleared Mar 09, 2007
ORISON EMBRACE SYSTEM
K070477 · IYO
Orison Corporation
Radiology · 17d
Cleared Mar 09, 2007
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
K070508 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 09, 2007
PHILIPS ESSENTA DR
K070528 · MQB
Philips Medical Systems GmbH, Dmc
Radiology · 14d
Cleared Mar 08, 2007
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
K063149 · OAT
T.O.A.D.S., LLC
Dental · 143d
Cleared Mar 08, 2007
PCA CONSTRAINED ACETABULAR LINERS
K063445 · KWZ
Howmedica Osteonics Corp.
Orthopedic · 113d
Cleared Mar 08, 2007
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473 · OAT
Synthes (Usa)
Dental · 112d
Cleared Mar 08, 2007
SYSTEM 12 CONSTRAINED ACETABULAR LINERS
K063550 · KWZ
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Mar 08, 2007
SERIES II CONSTRAINED ACETABULAR LINERS
K063552 · KWZ
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Mar 08, 2007
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
K070084 · EFA
Est. Anthogyr
Dental · 58d
Cleared Mar 08, 2007
ATRIUM PROLITE ULTRA S MESH
K070192 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 45d
Cleared Mar 08, 2007
LIV BREAST SELF EXAMINATION AID
K070344 · IZH
Liv International USA, Inc.
Radiology · 30d
Cleared Mar 07, 2007
ULTRA LOW PROFILE RONGEUR
K062711 · HAE
Baxano, Inc.
Neurology · 177d
Cleared Mar 07, 2007
SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
K063001 · GEX
Lasering S.R.L.
General & Plastic Surgery · 156d
Cleared Mar 07, 2007
CLAROS DENTAL LASER SYSTEM
K063152 · GEX
Elexxion AG
General & Plastic Surgery · 142d
Cleared Mar 07, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM...
K063486 · LON
Becton, Dickinson & CO
Microbiology · 110d