17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quattro Bolt Tenodesis Screw
FDA 510(k)
FDA Class 2
·Orthopedic
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·18100013402217·SINGLE INSTRUMENT
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·10840200302217·SINGLE INSTRUMENT
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 10, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 10, 2013
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 2, 2013
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·December 7, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·June 3, 2013
530 G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·September 27, 2014
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·June 29, 2011
PERF CON TIB BRG LRG 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
NON-POROUS PERF TIB TRAY-LGE
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PERF ANAT TIBIAL STEM 120X14X5
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024