16 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Advanced Intermezzo Implant System
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331184666·Yasargil Micro Bipolar Bayonet Forceps, flat ha...
VIDAS® BRAHAMS PROCALCITONIN
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PRI·June 4, 2019
PATIENT MONITOR, MODEL PM50
FDA 510(k)
FDA Class 2
·Cardiovascular
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 2, 2015
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 15, 2015
ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·October 21, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 26, 2013
PENTA 3MM LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 29, 2011
TOWEL OR 17X24IN BLUE STERILE 4/PK
FDA Adverse Event
Malfunction
·CARDINAL HEALTH SHANGHAI·Product code FRL·June 24, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·December 15, 2019
NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 25, 2020
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018