FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38521–38544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2014
CO PILOT/REGIUS UNITEA
K133730 · LLZ
Konica Minolta, Inc.
Radiology · 56d
Cleared Jan 31, 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD,...
K133796 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 49d
Cleared Jan 31, 2014
BREEZY ELEGANCE
K133855 · IOR
Sunrise Medical (Us), LLC
Physical Medicine · 43d
Cleared Jan 31, 2014
INTERBODY CAGE SYSTEM
K133967 · MAX
Aurora Spine
Orthopedic · 38d
Cleared Jan 31, 2014
6MP COLOR LCD MONITOR, RADIFORCE RX650
K134002 · LLZ
Eizo Corporation
Radiology · 35d
Cleared Jan 31, 2014
SORIN FLEXTHERM
K140012 · DWC
Sorin Group Deutschland GmbH
Cardiovascular · 29d
Cleared Jan 30, 2014
CARDIOCEL
K130872 · DXZ
Celxcel Pty, Ltd.
Cardiovascular · 307d
Cleared Jan 30, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131344 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 266d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833 · KWP
Orthofix, Inc.
Orthopedic · 224d
Cleared Jan 30, 2014
CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
K132474 · DXO
Acist Medical Systems
Cardiovascular · 176d
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