14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sotair Device
FDA 510(k)
FDA Class 2
·Anesthesiology
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113219599·Intent to be used with suture material for tiss...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514704·
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586016530·
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 9, 2021
PEREGRINE 23GA CURVED LASER PROBE
FDA 510(k)
FDA Class 2
·Ophthalmic
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 12, 2011
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023