15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPAR-K Instruments (for use with Gemini SL Total Knee System)
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465395·CDH HA COATED MAS 7.5X55
Sklar®
FDA UDI
SKLAR CORPORATION·10649111219214·KELLY TISSUE FCP 3X4 9"
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...
AIDI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
FDA 510(k)
FDA Class 2
·Hematology
ACCENT SR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013