18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUREFIRE GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131268631·ALTA PRO, DESIGNRITE 10 WL STG
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925032286·VENT TUBE 7 MM LENGTH 0.89 MM I.D. FLUOROPLASTIC
MAXIM KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304007611·
MAXIM® KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225109·
Easytech Anatomical Shoulder System
FDA UDI
FX SOLUTIONS·03701037301470·EASYTECH ANCHOR BASE TA6V Ø34 mm CEMENTLESS Ti/HA
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOGRAPHIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·December 13, 2017
DCM MAXIM PRIMARY TIBIAL BEARING 18MM THICK X 79/83MM WIDE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 1, 2017
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·May 29, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 25, 2011
MAXIM DCM POP-TOP TIBIAL CR BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 7, 2017
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 19, 2023
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 18, 2023
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 18, 2023
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013