131 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
FDA 510(k)
FDA Class 2
·Dental
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
RANDOX HUMAN ASSSAYED DRUG CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PURILENS SALINE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 10, 2025
REMSTAR AUTO A-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 12, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 5, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 13, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 14, 2026
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
FDA Enforcement
Class II
·Terminated·Solta Medical Inc·April 15, 2020
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 18, 2026
REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, FR
FDA Adverse Event
Injury
·RESPIRONICS, INC·Product code BZD·August 5, 2021
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 8, 2025
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 30, 2026
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
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·March 31, 2026