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
36865–36888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2014
FIT BELT
K133108 · NGX
Hong Qiangxing (Shenzhen) Electronics...
Physical Medicine · 309d
Cleared Aug 05, 2014
VITEK 2 AST - YEAST FLUCONAZOLE
K133817 · NGZ
bioMerieux, Inc.
Microbiology · 232d
Cleared Aug 05, 2014
INTRAVASCULAR ADMINISTRATION SET
K140175 · FPA
Delta Med Spa
General Hospital · 194d
Cleared Aug 05, 2014
Terumo Pen Injector Needle 34
K140516 · FMI
Kofu Factory of Terumo Corp.
General Hospital · 158d
Cleared Aug 05, 2014
VAPR ARCTIC SUCTION ELECTRODE
K140896 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 119d
Cleared Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056 · MBH
Stryker Orthopaedics
Orthopedic · 103d
Cleared Aug 05, 2014
RHYTHMSTAR SYSTEM
K141813 · DXH
RhythMedix, LLC
Cardiovascular · 29d
Cleared Aug 05, 2014
TURBO-JECT PICC SETS
K141818 · LJS
Cook Corporated
General Hospital · 29d
Cleared Aug 05, 2014
SENSEI X ROBOTIC CATHETER SYSTEM
K141822 · DXX
Hanson Medical, Inc.
Cardiovascular · 29d
Cleared Aug 05, 2014
SAPPHIRE ADMINISTRATION SET
K141834 · FPA
Q Core Medical , Ltd.
General Hospital · 29d
Cleared Aug 05, 2014
CLOSURERFG RADIOFREQUENCY GENERATOR
K141858 · GEI
Covidien
General & Plastic Surgery · 26d
Cleared Aug 04, 2014
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
K131230 · NBW
Philosys, Inc.
Chemistry · 461d
Cleared Aug 04, 2014
SKAFFOLD NMX BONE VOID FILLER
K132211 · MQV
Skeletal Kinetics, LLC
Orthopedic · 384d
Cleared Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
K140880 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 119d
Cleared Aug 04, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · MUD
Reflectance Medical, Inc.
Cardiovascular · 59d
Cleared Aug 04, 2014
UNIMICRO SUCTION IRRIATION TUBING SET
K141592 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 52d
Cleared Aug 04, 2014
AS20 COMPOSITE GRAFT
K141746 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Aug 04, 2014
LOGIQ V5/LOGIQ V3
K141768 · IYN
Ge Healthcare
Radiology · 34d
Cleared Aug 04, 2014
MEDICAL LCD MONITOR
K141891 · PGY
Kostec Co., Ltd.
Radiology · 21d
Cleared Aug 01, 2014
PASSPORT SERIES PATIENT MONITORS
K132662 · MHX
Shenzhen Mindray Biomedical...
Cardiovascular · 340d
Cleared Aug 01, 2014
TEBCO-W
K132892 · DXG
Bomed, Inc.
Cardiovascular · 319d
Cleared Aug 01, 2014
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K133461 · JEY
Stryker
Dental · 262d
Cleared Aug 01, 2014
ZOLL X SERIES
K133484 · MKJ
Zoll Medical Corp
Cardiovascular · 261d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · JWY
Thermo Fisher Scientific
Microbiology · 226d