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
39073–39096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 26, 2013
NEURODYN MULTIWAVE, AUSSIE SPORT
K131629 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 175d
Cleared Nov 26, 2013
DISPOSABLE INFUSION SET
K131646 · LHI
Shanghai Jinta Medical Co., Ltd.
General Hospital · 174d
Cleared Nov 26, 2013
EMOTION ECG MOBILE
K131699 · DXH
Mega Electronics , Ltd.
Cardiovascular · 168d
Cleared Nov 26, 2013
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
K131828 · LYZ
Jiangsu Handsafe Glove Co., Ltd.
General Hospital · 159d
Cleared Nov 26, 2013
CV3000 HOLTER ANALYSIS SYSTEM
K131897 · MLO
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 154d
Cleared Nov 26, 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS...
K131913 · DRG
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 153d
Cleared Nov 26, 2013
NEWTRON BOOSTER
K131997 · ELC
Satelec - Acteon Group
Dental · 151d
Cleared Nov 26, 2013
ASPIRE RX-LP6 ASPIRATION CATHETER
K131998 · QEZ
Control Medical Technology, LLC
Cardiovascular · 151d
Cleared Nov 26, 2013
SHASER V-MINI RX
K132170 · ONF
Shaser, Inc.
General & Plastic Surgery · 134d
Cleared Nov 26, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 119d
Cleared Nov 26, 2013
KNIT-PAK+
K132526 · MVL
Premier Dental Products Co.
Dental · 106d
Cleared Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · MBH
Stryker Orthopaedics
Orthopedic · 96d
Cleared Nov 26, 2013
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
K132699 · FTL
Tyrx, Inc.
General & Plastic Surgery · 89d
Cleared Nov 26, 2013
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · NQW
Spinefrontier, Inc.
Orthopedic · 84d
Cleared Nov 26, 2013
CYBERWAND STERILE PROBE SET
K132795 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
K132822 · NQX
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 78d
Cleared Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...
K133330 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Nov 25, 2013
DANA REUSABLE BI TEST PACK
K130135 · JOJ
Dana Products, Inc.
General Hospital · 311d
Cleared Nov 25, 2013
INBODY
K130777 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 249d
Cleared Nov 25, 2013
BIA / VITALITY ANALYZER
K130856 · MNW
Ipgdx, LLC
Gastroenterology & Urology · 242d
Cleared Nov 25, 2013
CAPNOMASK
K131339 · CCK
Mediplus , Ltd.
Anesthesiology · 200d
Cleared Nov 25, 2013
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
K132029 · OVE
Spinal USA
Orthopedic · 147d
Cleared Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · MNH
U&I Corporation
Orthopedic · 140d