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
37153–37176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
K140241 · OZT
Edwards Lifesciences, LLC
Cardiovascular · 154d
Cleared Jul 03, 2014
ASCEND
K140333 · NUH
Neurometrix, Inc.
Neurology · 143d
Cleared Jul 03, 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · DYB
Boston Scientific Corporation
Cardiovascular · 113d
Cleared Jul 03, 2014
POROUS COATED COMPREHENSIVE FRACTURE STEMS
K140652 · PHX
Biomet Manufacturing Corp
Orthopedic · 111d
Cleared Jul 03, 2014
DCAS I
K140869 · LLZ
Gp&P Co., Ltd.
Radiology · 91d
Cleared Jul 03, 2014
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1...
K140902 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 03, 2014
NORMED VARIO SUBTALAR SCREW
K140962 · HWC
Normed Nedizin Technik GmbH
Orthopedic · 79d
Cleared Jul 03, 2014
POD SYSTEM
K141134 · HCG
Penumbra, Inc.
Neurology · 63d
Cleared Jul 02, 2014
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
K132384 · HIH
Endosec Corporation
Obstetrics & Gynecology · 336d
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 275d
Cleared Jul 02, 2014
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM...
K133861 · LIT
Ostial Corporation
Cardiovascular · 195d
Cleared Jul 02, 2014
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
K140055 · MAX
Titan Spine, LLC
Orthopedic · 173d
Cleared Jul 02, 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY...
K140129 · DQE
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Jul 02, 2014
AP EXPANDABLE XLIF SYSTEM
K140162 · MAX
Nuvasive, Inc.
Orthopedic · 161d
Cleared Jul 02, 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260 · KWQ
Orthofix, Inc.
Orthopedic · 149d
Cleared Jul 02, 2014
ARROW GPSCATH BALLOON DILATATION CATHETER
K140351 · LIT
Hotspur Technologies,Inc Subsidiary...
Cardiovascular · 141d
Cleared Jul 02, 2014
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
K140512 · EBF
Juno Dentistry LP
Dental · 124d
Cleared Jul 02, 2014
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K140572 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 118d
Cleared Jul 02, 2014
NAVIO
K140596 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 02, 2014
FLOW-NAIL
K140601 · HSB
Flow-Fx, LLC
Orthopedic · 114d
Cleared Jul 02, 2014
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
K140685 · NYL
Sybron Endo
Dental · 106d
Cleared Jul 02, 2014
ISOSEED
K140849 · KXK
Eckert & Ziegler Bebig GmbH
Radiology · 90d
Cleared Jul 02, 2014
MCKESSON RADIOLOGY
K140909 · LLZ
Mckesson Medical Imaging Company
Radiology · 84d