24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111351822·CARDIO DUAL STETH 28" GREEN
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 28, 2013
9600+
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 27, 2007
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 18, 2011
UNSPECIFIED CENTRAL LINE TRANSDUCER SET
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·February 16, 2017
LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·July 10, 2017
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·December 4, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·February 9, 2017
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·December 19, 2018
LUNDERQUIST EXTRA-STIFF CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·April 20, 2017
LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DQX·June 16, 2017
LUNDERQUIST SUPPORT WIRE GUIDE
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DQX·May 31, 2017