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
56617–56640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2008
CPAP MASK
K071915 · BZD
Arcimed Laboratories, LLC
Anesthesiology · 308d
Cleared May 14, 2008
SIALO BALLOON DILATATION CATHETER
K072749 · GCJ
Sialo Technology, Ltd.
General & Plastic Surgery · 230d
Cleared May 14, 2008
INCLUSIVE IMPLANT ABUTMENTS
K073217 · NHA
Inclusive Dental Solutions
Dental · 181d
Cleared May 14, 2008
EASY GRIP DENTAL IMPLANT SYSTEM
K073622 · DZE
T.F.I. System S.R.L
Dental · 140d
Cleared May 14, 2008
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
K080128 · DZE
Dio Department Dsi, Inc.
Dental · 118d
Cleared May 14, 2008
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153 · MQN
Synthes (Usa)
Dental · 112d
Cleared May 14, 2008
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
K080165 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 112d
Cleared May 14, 2008
MPS ACACIA ENTERAL FEEDING TUBE
K080328 · KNT
Mps Acacia
Gastroenterology & Urology · 97d
Cleared May 14, 2008
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · IZL
Shimadzu Corp.
Radiology · 64d
Cleared May 14, 2008
CALYPSO 4D LOCALIZATION SYSTEM
K080726 · IYE
Calypso Medical Technologies, Inc.
Radiology · 61d
Cleared May 14, 2008
CONCEIVEX LATEX-FREE SEMEN COLLECTOR
K080752 · OBB
Conceivex, Inc.
Obstetrics & Gynecology · 58d
Cleared May 14, 2008
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
K080769 · MUD
Somanetics Corp.
Cardiovascular · 57d
Cleared May 14, 2008
3 CCD ENDOCAM 5550
K080977 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 37d
Cleared May 14, 2008
COLORISE RIGID
K081084 · ELW
Zhermack S.P.A.
Dental · 28d
Cleared May 14, 2008
SMARTSET MV BONE CEMENT
K081155 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared May 14, 2008
SMARTSET GMV GENTAMICIN BONE CEMENT
K081163 · MBB
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared May 14, 2008
STYLA MICROLASER AND STYLAORTHO
K081214 · GEX
Zap Lasers, LLC
General & Plastic Surgery · 14d
Cleared May 14, 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 1d
Cleared May 13, 2008
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
K073177 · MAX
Pioneer Surgical Technology
Orthopedic · 182d
Cleared May 13, 2008
OSTEOTRANS-OT PIN
K073311 · HTY
Takiron Co., Ltd.
Orthopedic · 172d
Cleared May 13, 2008
OSTEOTRANS-OT SCREW
K073312 · HWC
Takiron Co., Ltd.
Orthopedic · 172d
Cleared May 13, 2008
LITEDUO
K073411 · GEX
Light Instruments
General & Plastic Surgery · 161d
Cleared May 13, 2008
GRADUATED ADAPTER WITH CLAVE
K080007 · EZD
Icu Medical, Inc.
Gastroenterology & Urology · 132d
Cleared May 13, 2008
LEKSELL SURGIPLAN, MODEL 1006947
K080250 · HAW
Elekta Instrument AB
Neurology · 103d