646 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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IceFORCE" 2.1 CX L 90 Cryoablation Needle
FDA Recall
Completed
·Boston Scientific Corporation·Product code GEI·November 18, 2020
IcePearl" 2.1 CX L 90 Cryoablation Needle
FDA Recall
Completed
·Boston Scientific Corporation·Product code GEH·November 18, 2020
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Recall
Completed
·SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France·Product code HWC·October 7, 2021
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Enforcement
Class II
·Completed·SCIENCE & BIO MATERIALS·July 20, 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 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
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Completed
·ICU Medical, Inc.·Product code FMG·August 20, 2018
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
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