19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131234995·K50, CIC P 10 BE KIT
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003235·75 V2 EX SMALL 22ID STR W/HG
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694559·PROXIMITY VA SELF-TAP SCREW, 3.5 x 23mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545486·SPS VA Self-Tap Screw, 3.5 x 23 mm
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
FDA 510(k)
FDA Class 2
·General Hospital
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
FDA 510(k)
FDA Class 2
·General Hospital
REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 10, 2023
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 16, 2025
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 22, 2025
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 5, 2024
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 30, 2024
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·May 15, 2013
VOCALAID PROFILE TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·MANUFACTURED FOR SMITHS MEDICAL BY: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V·Product code JOH·June 6, 2008
ALIGN TO URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code FTL·June 1, 2011
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2023
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·July 17, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025