19 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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ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ConMed Linvatec
FDA UDI
Provision·B504OM50715380·
HALL
FDA UDI
Conmed Corporation·10845854033388·LARGE BONE HALL BLADE, OSCILLATING, 25.4 X 95 X...
NA
FDA UDI
STERILMED, INC.·10888551020824·SAW BLADE OSCILLATING LARGE BONE
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2023
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
UNKNOWN DEPUY 56MM MULTIHOLE SHELL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 15, 2011
UV-FLASH SOLUTION TRANSFER SET (SHORT)-JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 3, 2008
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 31, 1997
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022