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
41593–41616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K122431 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 172d
Cleared Jan 29, 2013
INION CPS ORBITAL PLATES
K122890 · JEY
Inion OY
Dental · 131d
Cleared Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067 · DQX
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 29, 2013
PROCEDURE REHEARSAL STUDIO
K123269 · LLZ
Simbionix , Ltd.
Radiology · 102d
Cleared Jan 29, 2013
A-SCAN PLUS CONNECT
K123349 · IYO
Accutome, Inc.
Radiology · 90d
Cleared Jan 29, 2013
PACIFIC PLUS
K123358 · LIT
Medtronic Vascular
Cardiovascular · 90d
Cleared Jan 29, 2013
BIOGRAPH MCT FAMILY
K123737 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jan 29, 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · MUE
Hologic, Inc.
Radiology · 43d
Cleared Jan 29, 2013
GE ECHOPAC
K123894 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 42d
Cleared Jan 29, 2013
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
K123901 · LLZ
Tractus Corporation
Radiology · 42d
Cleared Jan 29, 2013
IMAGEQUBE
K124048 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 29d
Cleared Jan 28, 2013
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY
K122156 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 192d
Cleared Jan 28, 2013
AXERA 2 ACCESS SYSTEM MODEL AXE200
K123135 · DYB
Arstasis, Inc.
Cardiovascular · 115d
Cleared Jan 28, 2013
MULTIPLE NAME
K123760 · LZA
Assurguard Sdn. Bhd.
General Hospital · 52d
Cleared Jan 25, 2013
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
K113375 · GXY
Eswallow USA
Neurology · 436d
Cleared Jan 25, 2013
LANTOS 3D EAR SCANNER
K121326 · ERA
Lantos Technologies
Ear, Nose, Throat · 268d
Cleared Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · MDB
bioMerieux, Inc.
Microbiology · 255d
Cleared Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · MDB
bioMerieux, Inc.
Microbiology · 254d
Cleared Jan 25, 2013
MEDYSSEY CANNULATED PEDICLE SCREW
K121670 · NKB
Medyssey Co, Ltd.
Orthopedic · 233d
Cleared Jan 25, 2013
ESA615
K121860 · DRT
Fluke Biomedical
Cardiovascular · 213d
Cleared Jan 25, 2013
ASA LASER SH1
K122125 · ILY
El.En Electronic Engineering Spa
Physical Medicine · 191d
Cleared Jan 25, 2013
SYSTEM 83 PLUS
K122172 · FEB
Custom Ultrasonics
General Hospital · 186d
Cleared Jan 25, 2013
LIAISON TESTOSTERONE
K122793 · CDZ
DiaSorin, Inc.
Chemistry · 135d
Cleared Jan 25, 2013
ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING...
K122797 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 135d