64 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPEEDCEM
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217634·
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258694689·
K091319
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 9, 2026
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI500 GLOBE-TROTTER TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
K09-10198 CONVENIENCE KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009
K09-10198 CONVENIENCE KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
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
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
REMSTAR
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 28, 2024
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·April 10, 2025
REMSTAR PRO C-FLEX+
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 7, 2026
AMPHIRION DEEP
FDA Adverse Event
Injury
·INVATEC SPA·Product code DQY·May 3, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
SECURE 2 MED/SURGBED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 11, 2011