15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYBER TM FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015
Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
Rumex
FDA UDI
RUMEX INTERNATIONAL CORP.·00840159907283·Ogura PVD Spatula, 23 Ga, Length 132 mm, Round ...
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Widex
FDA UDI
Widex A/S·05706069812466·Widex EVOKE E-PA (Tan silk ) 330, RC coil
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014
CORMET RESURFACING
FDA Adverse Event
Injury
·CORIN LTD.·Product code NXT·May 22, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015