14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
artegral life
FDA UDI
Merz Dental GmbH·D7091993023·anteriors; shade A1; mould UBL
Bipolar dissector
FDA UDI
SOPRO-COMEG GmbH·04059082014746·
HERITAGE III (HTC) ITC TYPE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PTFE PEELABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
ZMR®
FDA UDI
Zimmer, Inc.·00889024162211·
ZMR®
FDA UDI
Zimmer, Inc.·00889024162204·
ZMR®
FDA UDI
Zimmer, Inc.·00889024162198·
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code KXT·March 7, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·February 7, 2011
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026