10 results
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24ms
·
Sources: EU EUDAMED, US FDA
MUELLER-HINTON
FDA 510(k)
FDA Class 2
·Microbiology
ERA® RV DE Female Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549102226·The ERA RV DE Ti is an ERA distal extension att...
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581160800001·A-FIT® 1. MOLAR UPR RGT SZ 08
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
SLIC SCREW REPAIR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
T4/WD2418/HD/ADULT/28/BH16/1228/5244BK/COM/U550 9153639571
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 2, 2015
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·June 3, 2015
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Recall
Terminated
·Volk Optical Inc·Product code HJK·February 27, 2015