1,642 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·March 9, 2015
ALERE ORATECT
FDA Adverse Event
Injury
·AMEDITECH, INC.·Product code DJC·October 12, 2017
ALERE ORATECT
FDA Adverse Event
Injury
·AMEDITECH, INC.·Product code DJC·October 2, 2018
CHROMATOGRAPHY (THIN LAYER) CLINICAL USE - AMTOX DRUG DETECTION SYSTEM
FDA Adverse Event
Injury
·AMERITOX·Product code DJC·May 21, 2018
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 28, 2018
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 28, 2018
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LIX·January 29, 2018
Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code LIX·January 29, 2018
Thin Layer Chromatography, Methamphetamine
FDA classification
FDA Class 2
·Thin Layer Chromatography, Methamphetamine
dental diamond bur
FDA UDI
STRAUSS & CO - INDUSTRIAL DIAMONDS LTD·D877D0C6·Dental Diamond Bur
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551043096·1203-5 HALO VEST, PEDIATRIC 4, COOLMAX LINER
AVENTAMED DAC
FDA registration
AVENTAMED DAC·1 product·🇮🇪 Ireland
DDC TECHNOLOGIES, INC.
FDA registration
DDC TECHNOLOGIES, INC.·1 product·🇺🇸 United States
A-dec, Inc.
FDA registration
A-dec, Inc.·24 products·🇺🇸 United States
Subdural Electrode
FDA UDI
Ad-Tech Medical Instrument Corporation·00841823103796·