19 results
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22ms
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Sources: EU EUDAMED, US FDA
SPINE WORKS COLLAR
FDA 510(k)
FDA Class 2
·Neurology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092103425·CAMLOG® Screw-Line-compatible 6.0mm X 6mm Titan...
INSET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·November 20, 2024
RANDOX FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
CHASE CARDIOVASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 23, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 23, 2014
PROBE HOLDER
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code LXH·February 28, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 24, 2011
DEXTRUS SMALL ACCESS RETRACTOR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·February 14, 2008
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 15, 2020
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 29, 2024
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024