94 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MectaLock Extension
FDA 510(k)
FDA Class 2
·Orthopedic
Poly Stim II
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850958007395·2"x2" Cloth, Case of 10
Medical Science Private Label
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237900444·2"x2" Cloth,
Poly Stim II
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850958007398·2"x2" Cloth
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
FDA 510(k)
FDA Class 2
·Dental
PK ZIP WING CUTTING DISSECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD LOGIC BLOOD GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·October 17, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·November 23, 2016
SET SCREW, TI GAMMA3® Ø8X17.5MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·December 9, 2024
BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, SMALL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, SMALL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·November 27, 2024
BD MINIDRAW¿ FINGER SLEEVE, LARGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GIM·April 9, 2025