31 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925019423·EAR SURGERY SCISSORS-STRAIGHT
Cooley Ring-Bulldog Clamp 12,5cm
FDA UDI
Geister Medizintechnik GmbH·04057034060841·Cooley Ring-Bulldog Clamp 12,5cm
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020157·INTRG WHISP-Z ROTH 1BICHK -17T 0A 018 LR
Flexible Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067779·
PS 3000 DIGATAL PHOTOSPOT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PICCOLO COMPOSITE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 11, 2014
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 31, 2011
ACCU-CHEK ® COMPACT PLUS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·July 16, 2013
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025
MPACT ACETABULAR SYSTEM IMPLANTS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 6, 2026
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025