14 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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TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619044039·TD Torque-Line Catheter, 8F, 5 lumen, 110 cm, R...
8F TD CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·September 8, 2014
8F TD CATHETER
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code DYG·September 8, 2014
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LOW PROFILE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
TD TORQUE-LINE CATHETER (HEPARIN AND NON HEPARIN
FDA Adverse Event
Other
·ICU MEDICAL INC.·Product code DRS·August 16, 2013
PELVIC OSTEOTOME 15MM/304MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWM·August 30, 2019
HUDSON VOLDYNE 2500 VOLUMETRIC EXCERCISER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BWF·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 26, 2014
CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·June 14, 2011
Depuy P.F.C. E knee system, all polyethylene curved tibial component, Sz 2, 8 mm; Ref 96-0620.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023