8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Salix Central
FDA 510(k)
FDA Class 2
·Radiology
Gel-Block 10X embolization pledgets
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
FDA 510(k)
FDA Class 2
·General Hospital
ALTRX +4 NEUT 32IDX48OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 23, 2013
Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15
FDA Enforcement
Class II
·Terminated·Hospira Inc.·August 24, 2016
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021