69 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959061·DISTRACTOR 9091312 STR 12MM 4 DEG
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772003105·HUMERAL FRACTURE BRACE, RIGHT, SM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199021·AK3 Congruent Insert Trial Size 3, 12mm
EVIVA 0913-12
FDA UDI
Hologic, Inc.·15420045505322·PRODUCT, EVIVA, 9 GA, 13 CM LENGTH, 12MM APERTURE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450450550·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412510·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450458891·
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
FDA 510(k)
FDA Class 2
·Radiology
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EVIVA 0913-12
FDA Adverse Event
Injury
·HOLOGIC, INC·Product code KNW·January 5, 2024
EVIVA 0913-12
FDA Adverse Event
Injury
·HOLOGIC, INC·Product code KNW·January 5, 2024
EVIVA 0913-12
FDA Adverse Event
Injury
·HOLOGIC, INC·Product code KNW·June 25, 2025
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 12, 2026
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·August 5, 2021
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 24, 2022
REMSTAR PRO C-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·December 31, 2025
REMSTAR
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·October 22, 2024
BIPAP PRO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 5, 2026