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
49081–49104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2010
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007 · KWS
Tornier, Inc.
Orthopedic · 28d
Cleared Nov 09, 2010
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
K103041 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 26d
Cleared Nov 08, 2010
CAM STRUCTSURE BARS
K101582 · NHA
Biomet 3i, Inc.
Dental · 154d
Cleared Nov 08, 2010
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS)...
K101808 · HWC
Medshape Solutions
Orthopedic · 132d
Cleared Nov 08, 2010
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES
K101943 · LZA
Tangshan Jiteng Plastic Products Co.,...
General Hospital · 119d
Cleared Nov 08, 2010
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
K102073 · FPA
Benlan, Inc.
General Hospital · 108d
Cleared Nov 08, 2010
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
K102337 · LYZ
Curon Scientific Co., Ltd.
General Hospital · 82d
Cleared Nov 08, 2010
GRANDIO SO HEAVY FLOW
K102354 · EBF
Voco GmbH
Dental · 81d
Cleared Nov 08, 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA...
K102487 · LZO
Exactech, Inc.
Orthopedic · 70d
Cleared Nov 08, 2010
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
K102581 · ODC
Byrne Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 05, 2010
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · MNI
Life Spine
Orthopedic · 262d
Cleared Nov 05, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K101220 · MUJ
American Radiosurgery, Inc.
Radiology · 186d
Cleared Nov 05, 2010
PARIETEX PLUG AND PATCH
K101519 · FTL
Sofradim Production
General & Plastic Surgery · 156d
Cleared Nov 05, 2010
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
K101538 · HGY
Philips Electronics UK Limited
Obstetrics & Gynecology · 155d
Cleared Nov 05, 2010
ENDOSKELETON TO
K102067 · MAX
Titan Spine, LLC
Orthopedic · 105d
Cleared Nov 05, 2010
COMPACT TOUCH STS
K102198 · IYO
Quantel Medical S.A.
Radiology · 93d
Cleared Nov 05, 2010
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM
K102393 · IYO
Ge Medical System Israel , Ltd.
Radiology · 74d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 64d
Cleared Nov 05, 2010
LIFENET SYSTEM
K102757 · MSX
Physio-Control, Inc.
Cardiovascular · 43d
Cleared Nov 05, 2010
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · KWQ
Alphatec Spine, Inc.
Orthopedic · 38d
Cleared Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
K102975 · LPH
Exactech, Inc.
Orthopedic · 30d
Cleared Nov 04, 2010
RELIANCE SPINAL SCREW SYSTEM
K101112 · KWP
Reliance Medical Systems
Orthopedic · 197d
Cleared Nov 04, 2010
INTEGRITY MODEL 1014284
K102200 · IYE
Elekta , Ltd.
Radiology · 92d
Cleared Nov 04, 2010
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
K102388 · IYN
Ge Medical System Israel , Ltd.
Radiology · 73d