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
37321–37344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2014
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
K140562 · KNY
Leomed, LLC
Gastroenterology & Urology · 103d
Cleared Jun 16, 2014
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL
K140570 · EBI
Zest Anchors, LLC
Dental · 102d
Cleared Jun 16, 2014
NXSTAGE EXPRESS FLUID WARMER
K140623 · FLA
Nxstage Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jun 16, 2014
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR
K140708 · FRC
STERIS Corporation
General Hospital · 87d
Cleared Jun 16, 2014
PLANMECA ROMEXIS
K140713 · LLZ
Planmeca Oy
Radiology · 87d
Cleared Jun 16, 2014
BONASTENT BILIARY
K140760 · FGE
Endochoice, Inc.
Gastroenterology & Urology · 82d
Cleared Jun 16, 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · LYA
ArthroCare Corporation
Ear, Nose, Throat · 60d
Cleared Jun 14, 2014
REPROCESSED HARMONIC SHEAR
K132566 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 303d
Cleared Jun 13, 2014
DENTAL IMPLANT SYSTEM
K122807 · DZE
Hager& Meisinger GmbH
Dental · 652d
Cleared Jun 13, 2014
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE,...
K131080 · ILY
Reimers and Janssen GmbH
Physical Medicine · 445d
Cleared Jun 13, 2014
WINX SLEEP THERAPY SYSTEM
K132003 · OZR
Apnicure, Inc.
Anesthesiology · 347d
Cleared Jun 13, 2014
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
K132524 · JAK
Philips Medical Systems
Radiology · 305d
Cleared Jun 13, 2014
ONCENTRA BRACHY
K132816 · MUJ
Nucletron B.V.
Radiology · 277d
Cleared Jun 13, 2014
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
K132978 · PHJ
Sequenom, Inc.
Pathology · 263d
Cleared Jun 13, 2014
SENYINT PACS
K133098 · LLZ
Dalian Senyint Digital Medical System...
Radiology · 256d
Cleared Jun 13, 2014
KALARE
K133553 · JAA
Toshiba America Medical Systems, In.C
Radiology · 206d
Cleared Jun 13, 2014
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
K133661 · BZQ
Earlysense, Ltd.
Anesthesiology · 196d
Cleared Jun 13, 2014
BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM
K133884 · DZE
Biodenta Swiss AG
Dental · 175d
Cleared Jun 13, 2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
K140075 · MBH
United Orthopedic Corp.
Orthopedic · 151d
Cleared Jun 13, 2014
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
K140312 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Jun 13, 2014
740 SELECT
K140430 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jun 13, 2014
SU-POR SURGICAL IMPLANT
K140437 · KKY
Poriferous, LLC
General & Plastic Surgery · 112d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · GWO
Synthes USA Products, LLC
Neurology · 109d
Cleared Jun 13, 2014
MR ELASTOGRAPHY
K140666 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 87d