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
52585–52608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2009
TEPHAFLEX SURGICAL FILM
K091633 · OOD
Tepha, Inc.
General & Plastic Surgery · 64d
Cleared Aug 07, 2009
CDB FLIP-SIDE-CLIP BRACKET
K091702 · NJM
Cdb Corporation
Dental · 58d
Cleared Aug 07, 2009
FUJINON STERILE OVERTUBES
K091773 · FED
Fujinon, Inc.
Gastroenterology & Urology · 52d
Cleared Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700,...
K091856 · DRX
Conmed Corporation
Cardiovascular · 45d
Cleared Aug 07, 2009
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
K091995 · NKB
Allez Spine, LLC
Orthopedic · 36d
Cleared Aug 07, 2009
SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
K092064 · OBJ
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 07, 2009
MONOPOLY PEDICLE SCREW SYSTEM
K092073 · NKB
Signus Medical
Orthopedic · 30d
Cleared Aug 07, 2009
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003,...
K092075 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 29d
Cleared Aug 07, 2009
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
K092136 · KXK
Isoray Medical, Inc.
Radiology · 23d
Cleared Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
K092299 · DQY
Ev3, Inc.
Cardiovascular · 9d
Cleared Aug 07, 2009
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 3d
Cleared Aug 06, 2009
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO...
K083603 · GWN
Neuro Kinetics
Ear, Nose, Throat · 244d
Cleared Aug 06, 2009
MINI TIGHTROPE
K090107 · HTN
Arthrex, Inc.
Orthopedic · 203d
Cleared Aug 06, 2009
MONTERIS MEDICAL UFO
K090240 · HAW
Monteris Medical,
Neurology · 185d
Cleared Aug 06, 2009
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS,...
K090358 · LEG
Abbott Laboratories, Inc.
Chemistry · 175d
Cleared Aug 06, 2009
SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
K091167 · FMF
Shina Corp.
General Hospital · 106d
Cleared Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K091289 · DHB
Siemens Healthcare Diagnostics
Immunology · 97d
Cleared Aug 06, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K091365 · KWP
Medtronic Soafamor Danek
Orthopedic · 90d
Cleared Aug 06, 2009
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
K091460 · JJX
American Biological Technologies, Inc.
Chemistry · 80d
Cleared Aug 06, 2009
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
K092079 · IYN
Ge Medical Systems Israel,...
Radiology · 28d
Cleared Aug 06, 2009
BEYONDIMAGE WORKSTATION
K092235 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Aug 05, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329 · LSR
Viramed Biotech AG
Microbiology · 356d
Cleared Aug 05, 2009
RT300-SL, MODEL FA100052
K090750 · GZI
Restorative Therapies, Inc.
Neurology · 138d
Cleared Aug 05, 2009
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
K091396 · KWQ
Cardo Medical Corp.
Orthopedic · 87d