9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECISION GLIDE - ENHANCED SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAPSURE(R) PS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
START-X TIP EMS INSERT 3
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·March 4, 2026
ENDOTAK DSP
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVY·January 11, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 24, 2010
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·July 3, 2014
CEEON
FDA Adverse Event
Injury
·PHARMACIA & UPJOHN GRONINGEN·Product code HQL·March 18, 2003
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018