10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803130·Converse Alar Retractors, Double ended, sharp, ...
My Medical
FDA UDI
My Medical Store LLC·G4251106480·Converse Alar Retractor 12 cm
110-648
CERSR ELECTROMYOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
HI-TORQUE WINN GUIDE WIRE FAMILY
FDA 510(k)
FDA Class 2
·Cardiovascular
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014
EMPERION
FDA Adverse Event
Injury
·SMITH AND NEPHEW, INC·Product code LZO·June 1, 2011
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021