14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRUE SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131256225·NERA PRO, MINIBTE 312 WL 85 CBE
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
FDA 510(k)
FDA Class 2
·Orthopedic
1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 25, 2017
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2014
VIRTUOSO II DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 6, 2019
Lifeshield, latex-free Primary I.V. Set, convertible pin, 106 inch with backcheck valve and 3 pre-pierced injections sites, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11309-58.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
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