30 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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RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902757754·INSTRUMENT 8161210 2PRNG 10MM S STPL TRL
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190684·+1/+3 Distal Cutting Block
Compression Staple System
FDA UDI
TORNIER, INC.·00846832058716·Staple
T:SLIM (TM) INSULIN DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
FDA 510(k)
FDA Class 2
·Anesthesiology
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082345·Interbody Fusion Device, 16mm (W), 12mm (D), 10...
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082413·Interbody Fusion Device, 16mm (W), 12mm (D), 10...
INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 2, 2016
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 2, 2019
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·November 16, 2016
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 8, 2016
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468081225·Trial, 16mm (W), 12mm (D), 10mm (H), 7° Lordosis
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 23, 2015
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468081782·Rasping Trial, 16mm (W), 12mm (D), 10mm (H), 7°...
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·February 19, 2019
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246789089·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246789157·
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013