10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743601·LEVAMED ANKLE SUPPORT SAND III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477450·
SIMPLICT
FDA 510(k)
FDA Class 2
·Radiology
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
ASR 300 SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 15, 2011
SHUNTASSISTANT 35
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JXG·July 3, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018