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

Filters: Cleared only ×
175,820 results
39601–39624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · KWQ
Corelink, LLC
Orthopedic · 72d
Cleared Dec 05, 2013
STARCERAM
K133213 · EIH
H.C. Starck Ceramics GmbH
Dental · 48d
Cleared Dec 05, 2013
AEQUALIS HUMERAL NAIL
K133376 · HSB
Tornier, Inc.
Orthopedic · 31d
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411 · GNX
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Dec 05, 2013
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP...
K133425 · FTD
Engineered Medical Solutions Co., LLC
General & Plastic Surgery · 27d
Cleared Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · FJI
Nipro Medical Corporation
Gastroenterology & Urology · 435d
Cleared Dec 04, 2013
SELF-RETAINING BICANALICULUS INTUBATON SET II
K130375 · OKS
Fci Sas (France Chirurgie...
Ophthalmic · 293d
Cleared Dec 04, 2013
MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E...
K131957 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 160d
Cleared Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
K131961 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 160d
Cleared Dec 04, 2013
BM3/BM3 PLUS
K132033 · MWI
Noblitt & Rueland
Cardiovascular · 156d
Cleared Dec 04, 2013
S HEALTH
K132148 · DRG
Samsung Electronics Co., Ltd.
Cardiovascular · 146d
Cleared Dec 04, 2013
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
K132232 · OCW
Minilap Technologies
Gastroenterology & Urology · 139d
Cleared Dec 04, 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · DQK
Ge Medical Systems Information...
Cardiovascular · 121d
Cleared Dec 04, 2013
MYLABSEVEN 6400, MYLABALPHA 7400
K132466 · IYN
Esaote, S.P.A.
Radiology · 119d
Cleared Dec 04, 2013
CARESCAPE MONITOR B450
K132533 · MHX
GE Healthcare Finland Oy
Cardiovascular · 114d
Cleared Dec 04, 2013
PERIMETER C SPINAL SYSTEM
K132584 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 110d
Cleared Dec 04, 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · MWI
Covidien
Cardiovascular · 106d
Cleared Dec 04, 2013
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
K132748 · EBF
Shofu Dental Corporation
Dental · 92d
Cleared Dec 04, 2013
ELECSYS CALCITONIN
K132828 · JKR
Roche Diagnostics
Chemistry · 86d
Cleared Dec 03, 2013
AVANT LASER
K123474 · ILY
Avant Wellness Systems, LLC
Physical Medicine · 385d
Cleared Dec 03, 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K130329 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 295d
Cleared Dec 03, 2013
SURVEYOR CENTRAL STATION
K131929 · MHX
Mortara Instrument, Inc.
Cardiovascular · 159d
Cleared Dec 03, 2013
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
K132463 · NEU
Cianna Medical, Inc.
General & Plastic Surgery · 118d
Cleared Dec 03, 2013
M-VU BREAST DENSITY
K132742 · LLZ
Vucomp, Inc.
Radiology · 91d