14 results · 20ms · Sources: EU EUDAMED, 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