16 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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eKare inSight
FDA UDI
E-Kare Inc.·00860003459850·System for wound measurement and management.
EKARE INC.
FDA registration
EKARE INC.·2 products·🇺🇸 United States
CARELINK CONNECT APP ANDROID
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 7, 2023
CARELINK CONNECT APP ANDROID
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 6, 2023
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 7, 2023
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 8, 2023
CARELINK PERSONAL MMT-7333
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·November 9, 2023
SMARTPHONE ANDROID APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 8, 2023
COCR HEAD 32/ 0 'M' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·March 14, 2017
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDI·December 2, 2014
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 31, 2023
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 22, 2023
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDI·December 2, 2014
CARELINK CONNECT APP IOS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 21, 2023
Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011
Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011