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

Filters: Cleared only ×
176,076 results
54865–54888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · JAK
Toshiba America Medical Systems, In.C
Radiology · 35d
Cleared Dec 12, 2008
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
K083370 · QEW
Artegraft, Inc.
Cardiovascular · 28d
Cleared Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
K083379 · GEX
Cynosure, Inc.
General & Plastic Surgery · 28d
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 22d
Cleared Dec 12, 2008
GE DISCOVERY NM/CT 570C
K083504 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 16d
Cleared Dec 12, 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Dec 11, 2008
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
K070541 · ILX
Ivivi Technologies, Inc.
Physical Medicine · 654d
Cleared Dec 11, 2008
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · MKZ
Becton, Dickinson & CO
Microbiology · 167d
Cleared Dec 11, 2008
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
K081825 · LSL
Becton, Dickinson & CO
Microbiology · 167d
Cleared Dec 11, 2008
BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
K081972 · LZA
Nitritex (M) Sdn. Bhd.
General Hospital · 154d
Cleared Dec 11, 2008
BIONET BM3PLUS PATIENT MONITOR
K082008 · MWI
Bionet Co., Ltd.
Cardiovascular · 149d
Cleared Dec 11, 2008
CHAPERON GUIDING CATHETER
K082385 · DQY
MicroVention, Inc.
Cardiovascular · 114d
Cleared Dec 11, 2008
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K082559 · DQY
Spectranetics Corp.
Cardiovascular · 98d
Cleared Dec 11, 2008
HERCULITE ULTRA
K082671 · EBF
Sybron Dental Specialties
Dental · 87d
Cleared Dec 11, 2008
BEAUTIBOND
K082744 · KLE
Shofu Dental Corp.
Dental · 84d
Cleared Dec 11, 2008
MESA AND RANGE SPINAL SYSTEMS
K082769 · KWP
K2m, Inc.
Orthopedic · 80d
Cleared Dec 11, 2008
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
K082770 · HSB
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2008
CLAMPFIX
K082914 · NKB
Synthes Spine
Orthopedic · 72d
Cleared Dec 11, 2008
CAPSURE(R) PS SYSTEM
K083353 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM...
K083364 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 11, 2008
CUSTOM COMFORT NIGHTGUARD
K083400 · OBR
Den Tek Oral Care, Inc.
Dental · 24d
Cleared Dec 11, 2008
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
K083560 · ILY
Lighthouse Technical Innovations, Inc.
Physical Medicine · 9d
Cleared Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,...
K071474 · NTV
Siemens Healthcare Diagnostics
Chemistry · 561d
Cleared Dec 10, 2008
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 555d