19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vitalograph Model 6600 Compact
FDA 510(k)
FDA Class 2
·Anesthesiology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016197·Double Meniscus Cutter 4,2
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
FDA 510(k)
FDA Class 2
·Cardiovascular
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
FDA 510(k)
FDA Class 2
·Radiology
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 26, 2014
TAP III
FDA Adverse Event
Malfunction
·AIRWAY MANAGEMENT, INC·Product code LRK·April 29, 2011
REVEL
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·October 10, 2015
EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES LLC·Product code NPT·February 6, 2018
5.5 EXP VERSE DI SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE CAN SCR 7.0X45
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE CAN SCR 7.0X45
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE DI SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE DI SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE CAN SCR 7.0X45
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE DI SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024