21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDRAD STELLANT CT INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DRX - Ascend System
FDA UDI
CARESTREAM HEALTH, INC.·60889971023186·DRX-ASCEND SYSTEM/QG-40-4-R10-T140
Reprocessed Micro Sagittal Blade, Fine, 9.5 x 25.5 x 0.4mm
FDA UDI
SURETEK MEDICAL·B39050231831·
Conmed/Linvatec
FDA UDI
Provision·B504OM50231830·
Conmed/Linvatec
FDA UDI
Provision·00810041065735·
NA
FDA UDI
STERILMED, INC.·10888551019873·SAW BLADE SAGITTAL MICRO ACL FINE TOOTH
CONMED
FDA UDI
Conmed Corporation·10845854003978·ACL BLADE, FINE, 9.5 X 25.5 X 0.4 MM
PISCES PLUS (DW286 C)
FDA 510(k)
FDA Class 2
·Dental
THERMAGE THERMACOOL II SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEE H10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FRN·February 27, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 16, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
Y-90 THERASPHERE
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·June 22, 2023
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025