15 results · 23ms · Sources: EU EUDAMED, 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