31 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
RADICAL
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·April 16, 2015
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526784987·EPICOMED ELBOW SUPPORT SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743557·LEVAMED ANKLE SUPPORT SILVER IV
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023970·PADDLE SPREADER, 14MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102140·Shaver, Open 14mm
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742112206·LYNX Distal Humeral Locking Plate Medial Anatom...
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193025401·B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT...
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDIAL ROTATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Injury
·MATORHTO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016