16 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICR02 OSA DEVICE
FDA 510(k)
FDA Class 2
·Dental
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
FDA 510(k)
FDA Class 1
·General Hospital
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2027971-2021-133683
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·November 25, 2021
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 3, 2013
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 29, 2013
CHOLESTEROL GEN.2
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CHH·June 20, 2011
ANGIOGUARD RX
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code NTE·August 20, 2008
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024
3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 30MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 5, 2020
3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 30MM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 5, 2020
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023