12 results
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18ms
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Sources: EU EUDAMED, US FDA
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074088020·SPACER 2940169 COMBO TOOL
VARIAX
FDA UDI
Stryker GmbH·07613327126068·Module - LCL Plates
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150768·K-WIRE - SINGLE TROCAR 1.6mm DIA x 230mm
SYNTHES MANDIBLE EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Dental
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 23, 2010
SAFIRE BLU DUO CATHETER, 1304-CP2S-7-25-MC-BD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·March 21, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019