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

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176,076 results
59569–59592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2007
ROC LUMBAR SYSTEM
K063668 · MNI
Alphatec Spine, Inc.
Orthopedic · 158d
Cleared May 18, 2007
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K070047 · MQK
Nunc A/S
Obstetrics & Gynecology · 134d
Cleared May 18, 2007
WALLABY 4
K070180 · LBI
Respironics Inc., Sleep & Home...
General Hospital · 119d
Cleared May 18, 2007
BODYGUARD PAIN MANAGER INFUSION SYSTEM
K070235 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 113d
Cleared May 18, 2007
EZ PLUS IMPLANT SYSTEM
K070562 · NHA
Megagen Co., Ltd.
Dental · 80d
Cleared May 18, 2007
COFIELD TOTAL SHOULDER SYSTEM
K070565 · MBF
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared May 18, 2007
NEXFIX COMPRESSION STAPLE
K070688 · JDR
Nexa Orthopedics, Inc.
Orthopedic · 67d
Cleared May 18, 2007
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
K070834 · OWB
Omega Medical Imaging, Inc.
Radiology · 52d
Cleared May 18, 2007
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION...
K070964 · HIB
Welch Allyn, Inc.
Obstetrics & Gynecology · 43d
Cleared May 18, 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · CAF
Apex Medical Corp.
Anesthesiology · 39d
Cleared May 18, 2007
.DECIMAL APERTURE
K071077 · IXI
.Decimal, Inc.
Radiology · 31d
Cleared May 18, 2007
ASPIRA PLEURAL DRAINAGE SYSTEM
K071095 · DWM
Bard Access Systems, Inc.
Anesthesiology · 30d
Cleared May 18, 2007
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
K071117 · KWZ
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared May 18, 2007
SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
K071204 · IYO
C.R. Bard, Inc.
Radiology · 17d
Cleared May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared May 18, 2007
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
K071267 · LBH
Novamin Technology, Inc.
Dental · 11d
Cleared May 17, 2007
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
K063806 · CBK
Sleepnet Corporation
Anesthesiology · 146d
Cleared May 17, 2007
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
K070284 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 108d
Cleared May 17, 2007
SERADYN QMS TOPIRAMATE
K070645 · NWM
Seradyn, Inc.
Toxicology · 70d
Cleared May 17, 2007
MODIFICATION TO BILOK SCREW
K071091 · HWC
Biocomposites, Ltd.
Orthopedic · 29d
Cleared May 17, 2007
MODIFICATION TO BILOK ST SCREW
K071115 · HWC
Biocomposites, Ltd.
Orthopedic · 27d
Cleared May 17, 2007
BLADDERSCAN BVI 9400 ULTRASOUND
K071217 · IYO
Verathon Incorporated
Radiology · 15d
Cleared May 17, 2007
EDAC QUANTIFIER
K071231 · KRL
Luna Innovations, Inc.
Cardiovascular · 14d
Cleared May 16, 2007
REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
K062525 · GEI
Ascent Healthcare Solutions
General & Plastic Surgery · 261d