17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BA310 Abutment, BIA310 Implant/Abutment
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269385·
Modular Tapered Pin Reamer
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055578·
HEMOSTASYL PASTE
FDA 510(k)
FDA Unclassified
·Unknown
DIGITAL CLINICAL THERMOMETER MODEL V901US
FDA 510(k)
FDA Class 2
·General Hospital
HAMILTON-C1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
3M ESPE SCOTCHBOND UNIVERSAL
FDA Adverse Event
3M DEUTSCHLAND GMBH·Product code KLE·October 8, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 21, 2013
DELTA XL
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·June 23, 2011
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021
COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025