11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HyperSuture White/Green Extension Line
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
24M - Salt River Project-21 - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588022017·24M - Salt River Project-21 - Metal
Portex
FDA UDI
ICU MEDICAL, INC.·15019517072587·
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123002·MORELAND REV INST STD FEMORAL EXTRACTOR STD
NOVEL VBR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OMNI Interface Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 9, 2011
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023