17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HealthICH
FDA 510(k)
FDA Class 2
·Radiology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721315·House Alligator Ear Forceps 3" (7.5cm) shaft, s...
PGA
FDA Adverse Event
Malfunction
·CP MEDICAL·Product code GAM·December 13, 2019
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
FDA 510(k)
FDA Class 2
·Cardiovascular
DVX SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·May 12, 2020
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR INREDWOOD CITY·Product code MGB·October 6, 2008
UNKNOWN DEPUY DURALOC ACETABULAR CUP
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 26, 2013
TRIDENT PSL HA CLUSTER 50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LPH·July 28, 2011
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021
MODULAR T-HANDLE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code LXH·December 17, 2024
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024