644 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Recall
Completed
·Abbott Molecular, Inc.·Product code MZP·July 19, 2022
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
FDA Enforcement
Class II
·Completed·Abbott Molecular, Inc.·August 24, 2022
SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F M RESS, .070", REF SA6MRESS. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;
FDA Enforcement
Class II
·Completed·Bolton Medical Inc.·April 3, 2024
Destino Twist 14F (also branded as Guidestar 14F)
FDA Enforcement
Class II
·Completed·Oscor Inc.·February 23, 2022
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;
FDA Recall
Completed
·Bolton Medical Inc.·Product code MIH·February 22, 2024
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
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Enforcement
Class II
·Completed·Beckman Coulter Mishima K.K.·June 11, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA Enforcement
Class II
·Completed·Beckman Coulter, Inc.·July 23, 2025
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·July 10, 2024
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Enforcement
Class II
·Completed·ESAOTE S.P.A.·March 11, 2026
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
FDA Enforcement
Class II
·Completed·Philips Ultrasound, LLC·January 7, 2026
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-030DC
FDA Enforcement
Class II
·Completed·Stryker Corporation·September 4, 2024
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 Enforcement
Class II
·Completed·Philips Ultrasound Inc·September 29, 2021
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA Enforcement
Class II
·Completed·Murata Vios, Inc.·January 22, 2025