15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6420 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
GF Health Products, Inc.
FDA registration
GF Health Products, Inc.·8 products·🇺🇸 United States
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
FDA 510(k)
FDA Class 2
·Cardiovascular
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
2183191-1998-00002
FDA Adverse Event
Other
·Product code FMS·September 23, 1998
2183191-1996-00001
FDA Adverse Event
Death
·Product code INX·October 18, 1996
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 26, 2024
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·June 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 17, 2014
HERMETIC LUMBAR CATHETER, OPEN TIP
FDA Adverse Event
Injury
·INTEGRA NEUROSCIENCES PR·Product code JXG·October 28, 2015
UNKN GENESIS UNI KNEE IMPL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025
UNKN GENESIS UNI KNEE IMPL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025
UNKN GENESIS UNI KNEE IMPL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 9, 2025
ADVANTA V12 COVERED STENT
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code NIO·February 24, 2021
OT VERIO FLEX METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 31, 2017