1,033 results · 15ms · Sources: EU EUDAMED, US FDA

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TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

FDA Recall
Completed ·Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JDI·July 12, 2022

Elekta Unity

FDA Recall
Completed ·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·January 4, 2019

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

FDA Recall
Completed ·Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom·Product code GCJ·June 2, 2022

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

FDA Recall
Completed ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code DTQ·March 13, 2023

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

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

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

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

FDA Enforcement
Class II ·Completed·Acumed LLC·April 27, 2022

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Enforcement
Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

FDA Enforcement
Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

FDA Enforcement
Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Enforcement
Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

FDA Enforcement
Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

FDA Enforcement
Class II ·Completed·Innomed, Inc.·May 8, 2024