23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
FDA 510(k)
FDA Class 2
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450205068·
BILOX PROSTHESIS HEAD 12/14 28MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
FDA 510(k)
FDA Class 2
·Cardiovascular
ANCURE LLIAC BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
TRUE BALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014
BIOLOX PROSTHESIS HEAD 12/14 32MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015
S-ROM*SLEEVE PRX ZTT, 20F-SML
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code LPH·May 6, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014