24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes Plates and Screws Portfolio
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103500·7.0 x 50mm Cannulated Screw, 16mm Thd
OsteoMed
FDA UDI
OSTEOMED LLC·00842528107867·7.0 x 50mm Cann Screw 16Thd Sterile 2Pk
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
FDA 510(k)
FDA Class 2
·Neurology
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024495470·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024495463·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024495487·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·October 7, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LPH·June 26, 2013
REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·December 11, 2025
INTELLAMAP ORION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·November 11, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023
CENTRIFUGAL PUMP REVOLUTION 5
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·August 3, 2023