12 results
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25ms
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Sources: EU EUDAMED, US FDA
AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
FDA 510(k)
FDA Class 1
·Ophthalmic
Nexxis
FDA UDI
Barco NV·05415334002364·MNA-420 ENC HDMI
N/A
FDA UDI
Tyber Medical, LLC·M695M9303200·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515238046·Adson Dural Hook, 3mm shrp hk, 7 3/4"
BOSS Instruments
FDA UDI
Provision·B504GS9303200·
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·January 23, 2013
PENUMBRA SYSTEM ASPIRATION PUMP CANISTER
FDA Adverse Event
Malfunction
·PENUMBRA INC.·Product code BTA·November 18, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OYC·July 11, 2014
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025