29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
FDA 510(k)
FDA Class 2
·Orthopedic
Bard® Blakemore Esophageal-Nasogastric Tube
FDA UDI
C. R. Bard, Inc.·00801741076817·Bard® Blakemore Esophageal-Nasogastric Tube
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959139·DISTRACTOR 9092110 STRGHT HOUSING 10MM
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 110mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036732·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198413·AK3 Ultra Insert Trial Size 1, 10mm
SPL CRIMP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DRI ECSTASY ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SLEEPEASY
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·April 12, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 6, 2010
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·November 25, 2009
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KNT·January 23, 2026
BARD® BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KNT·January 13, 2026
Bard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code KNT·April 17, 2025
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·May 3, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 27, 2011
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
FDA Enforcement
Class I
·Ongoing·C.R. Bard Inc·May 28, 2025
REMSTAR PLUS M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·March 16, 2012
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·February 24, 2010