131 results · 30ms · Sources: EU EUDAMED, 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