18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Philips Incisive CT
FDA 510(k)
FDA Class 2
·Radiology
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
PANAVIA F
FDA 510(k)
FDA Class 2
·Dental
FLAT TITANIUM PECTUS BAR 10.5
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
FLAT TITANIUM PECTUS BAR 12
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
FLAT TITANIUM PECTUS BAR 13IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
FLAT TITANIUM PECTUS BAR 13IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 17, 2023
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025
FLAT TITANIUM PECTUS BAR 12.5
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021