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
39121–39144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2014
UV PHOTOTHERAPY
K132643 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 157d
Cleared Jan 30, 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
K132746 · NHA
Nobel Biocare USA, LLC
Dental · 149d
Cleared Jan 30, 2014
DIGITAL ELECTROCARDIOGRAPH
K132758 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 148d
Cleared Jan 30, 2014
DOME S10
K132770 · LLZ
Nds Surgical Imaging
Radiology · 148d
Cleared Jan 30, 2014
ARDIS INTERBODY SYSTEM
K133184 · MAX
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Jan 30, 2014
MECTALIF TIPEEK
K133192 · MAX
Medacta International
Orthopedic · 105d
Cleared Jan 30, 2014
TITANIUM SUTURE ANCHOR
K133229 · MBI
Mtp Solutions, LLC
Orthopedic · 101d
Cleared Jan 30, 2014
MINI TIGHTROPE
K133275 · HTN
Arthrex, Inc.
Orthopedic · 98d
Cleared Jan 30, 2014
CRUX SNARE FILTER RETRIEVAL SET
K133681 · MMX
Volcano Corporation
Cardiovascular · 59d
Cleared Jan 30, 2014
ARTHREX BIOSUTURE
K140019 · GAT
Arthrex, Inc.
General & Plastic Surgery · 27d
Cleared Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204 · DQY
Cook, Inc.
Cardiovascular · 275d
Cleared Jan 29, 2014
UA-CELLULAR COMPLETE
K131444 · JJW
Streck
Chemistry · 254d
Cleared Jan 29, 2014
MOORLDLS-BI LASER DOPPLER BURNS IMAGER
K132163 · DPT
Moor Instruments, Ltd.
Cardiovascular · 201d
Cleared Jan 29, 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721 · LYA
Spiway, LLC
Ear, Nose, Throat · 152d
Cleared CT Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · LPL
Ciba Vision Corporation
Ophthalmic · 104d
Cleared Jan 29, 2014
TANDEMHEART FEMORAL VENOUS CANNULA SET
K133236 · DWF
Cardiacassist, Inc.
Cardiovascular · 100d
Cleared Jan 29, 2014
CADWELL FLEX EEG/PSG
K133355 · GWQ
Cadwell Industries, Inc.
Neurology · 90d
Cleared Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330 · LJM
Gold Standard Diagnostics
Immunology · 265d
Cleared Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · KTT
Zimmer, Inc.
Orthopedic · 257d
Cleared Jan 28, 2014
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
K133541 · HRS
Emerge Medical
Orthopedic · 71d
Cleared Jan 28, 2014
OTC PATCH
K133723 · NUH
Well-Life Healthcare Limited
Neurology · 53d
Cleared Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
K131244 · CEC
Roche Diagnostics
Chemistry · 271d
Cleared Jan 27, 2014
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
K131309 · IMI
Ibramed Equipamentos Medicos
Physical Medicine · 265d
Cleared Jan 27, 2014
ATAMA SYSTEM
K132444 · MOS
Monteris Medical,
Radiology · 174d