14 results
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18ms
·
Sources: EU EUDAMED, US FDA
Maverick RNP Assay and Maverick Diagnostic System
FDA 510(k)
FDA Class 2
·Immunology
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105514R1·IN-OVATION® mini Rhodium Base Rx 018 UL/5-5 CS ...
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055241·IN-OVATION® mini Base Rx 022 UL/5-5 CS BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523P1·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK PSV
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055131·IN-OVATION® mini Base Rx 018 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055231·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105524R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS B...
SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SHARPS TANK REUSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
ENDURANCE BONE CEMENT 80G
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·June 26, 2013
ENDO TOOL SOFTWARE
FDA Adverse Event
Malfunction
·HOSPIRA POINT OF CARE SOLUTIONS·Product code NDC·July 25, 2011
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·September 24, 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