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
36817–36840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2014
SUPERNOVA C5 MRI SYSTEM
K131737 · LNH
Liaoning Kampo Medical System Co., Ltd.
Radiology · 497d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157 · DRY
Medtronic, Inc.
Cardiovascular · 371d
Cleared Oct 23, 2014
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140205 · CAC
Teleflexmedical, Inc.
Anesthesiology · 269d
Cleared Oct 23, 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · HEX
CooperSurgical, Inc.
Obstetrics & Gynecology · 211d
Cleared Oct 23, 2014
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
K141125 · EGS
Handpiece Headquarters
Dental · 175d
Cleared Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K141325 · HKI
Topcon Corp.
Ophthalmic · 156d
Cleared Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 155d
Cleared Oct 23, 2014
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · FTL
Ethicon, Inc.
General & Plastic Surgery · 133d
Cleared Oct 23, 2014
HEMOPORE
K141816 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 108d
Cleared Oct 23, 2014
RAYSTATION
K141860 · MUJ
Raysearch Laboratories AB
Radiology · 105d
Cleared Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
K142101 · MAX
Spine Wave, Inc.
Orthopedic · 83d
Cleared Oct 23, 2014
Vasc Band hemostat
K142359 · DXC
Lepu Medical Technology (Beijing)...
Cardiovascular · 59d
Cleared Oct 23, 2014
Flexible Video-Uretero-Choledochoscope System
K142556 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 23, 2014
Stryker Precision HD Camera System
K142603 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 38d
Cleared Oct 23, 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698 · MQB
Perkinelmer, Inc.
Radiology · 31d
Cleared Oct 23, 2014
Siemens 3.0 Blanket Array Coil
K142755 · MOS
Resonance Innovations, LLC
Radiology · 28d
Cleared Oct 23, 2014
LiNA PowerBlade Plus HC
K142757 · GEI
Lina Medical Aps
General & Plastic Surgery · 28d
Cleared Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Oct 22, 2014
VANTERA CLINICAL ANALYZER
K133849 · NSU
Liposcience
Chemistry · 307d
Cleared Oct 22, 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K140251 · MQB
Meridian Medical Systems, LLC
Radiology · 264d
Cleared Oct 22, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
K141211 · NHA
Prismatik Dentalcraft, Inc.
Dental · 166d
Cleared Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
K141491 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 139d
Cleared Oct 22, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
K141544 · NHA
Zimmer Dental, Inc.
Dental · 134d
Cleared Oct 22, 2014
Ultra Silver Dressings
K141603 · FRO
Milliken Healthcare Products, LLC
General & Plastic Surgery · 128d