29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NightOwl
FDA 510(k)
FDA Class 2
·Anesthesiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111111259·DUPLAY DRESSING FCP CVD 8"
Trocar sleeve
FDA UDI
SOPRO-COMEG GmbH·04059082004785·
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082004808·
9.1MHZ PENCIL PROBE 7'
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787021431·
Trocar sleeve
FDA UDI
SOPRO-COMEG GmbH·04059082004778·
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082004815·
PIONEER SURGICAL NANOSS BVF-E
FDA 510(k)
FDA Class 2
·Orthopedic
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 20, 2012
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MNH·December 4, 2009
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 2, 2013
COLORADO II SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·May 19, 2017
COLORADO SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 17, 2016
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·March 19, 2013
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 21, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 26, 2013
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·July 29, 2011