6 results
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47ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
FDA Enforcement
Class II
·Completed·Abbott Laboratories, Inc·November 29, 2017
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYO·August 6, 2021
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYO·August 6, 2021
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Recall
Completed
·Mako Surgical Corporation·Product code OLO·October 23, 2020