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
40057–40080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2013
ROLLINS 7 OXYGEN MASK
K130379 · CAF
Rollins Medical Solutions, Inc.
Anesthesiology · 237d
Cleared Oct 09, 2013
COMPREHENSIVE CONVERTIBLE GLENOID
K130390 · PHX
Biomet Manufacturing, Inc.
Orthopedic · 236d
Cleared Oct 09, 2013
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
K131207 · HQF
Surgical Instrument Engineering AG
Ophthalmic · 163d
Cleared Oct 09, 2013
AU BICARBONATE REAGENT
K131546 · KHS
Beckman Coulter Ireland, Inc.
Chemistry · 133d
Cleared Oct 09, 2013
HAMILTON-G5
K131774 · CBK
Hamilton Medical AG
Anesthesiology · 114d
Cleared Oct 09, 2013
CEZANNE II INTERBODY FUSION SYSTEM
K131981 · MAX
Accel Spine
Orthopedic · 103d
Cleared Oct 09, 2013
VIDAS C DIFFICILE GDH
K132010 · MCB
Biomerieux S.A.
Microbiology · 100d
Cleared Oct 09, 2013
SYNERGY ODM
K132667 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 43d
Cleared Oct 09, 2013
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
K132704 · LXT
Biomet
Orthopedic · 41d
Cleared Oct 09, 2013
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
K132819 · HIL
Playtex Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 08, 2013
MEDDUSA BIPOLAR SYSTEM
K130110 · GEI
Elliquence, LLC
General & Plastic Surgery · 265d
Cleared Oct 08, 2013
R7
K130834 · ELC
Cefla S.C.
Dental · 196d
Cleared Oct 08, 2013
PRONTOSAN WOUND GEL X
K130857 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 194d
Cleared Oct 08, 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · GXQ
Cook Biotech, Inc.
Neurology · 180d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · HRS
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 08, 2013
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
K131353 · PHX
Biomet Manufacturing Corp
Orthopedic · 151d
Cleared Oct 08, 2013
INMODE WMBODY DEVICE
K131362 · NUV
Inmode MD , Ltd.
General & Plastic Surgery · 148d
Cleared Oct 08, 2013
APEX KNEE MODULAR TIBIA SYSTEM
K131472 · JWH
Omni Life Science, Inc.
Orthopedic · 139d
Cleared Oct 08, 2013
INTEL-GE CARE INNOVATIONS QUIETCARE
K131585 · KMI
Intel-Ge Care Innovations, LLC
General Hospital · 130d
Cleared Oct 08, 2013
NERIA SOFT 90 INFUSION SET
K132142 · FPA
Unomedical A/S
General Hospital · 89d
Cleared Oct 08, 2013
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
K132224 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 83d
Cleared Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · OCW
Teleflexmedical, Inc.
General & Plastic Surgery · 70d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 08, 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589 · KWQ
Life Spine, Inc.
Orthopedic · 50d