15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERIPHERAL GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541305·RZ Tebbet Breast Retractor
70x16m...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 7, 2025
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
SHARP BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 22, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 15, 2011
PROGAV W/SHUNTASSIST .25 + DIST. CATH
FDA Adverse Event
Malfunction
·AESCULAP AG & CO, KG·Product code JXG·July 3, 2008
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·February 28, 2016
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