12 results · 36ms · Sources: EU EUDAMED, US FDA

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STERISAFE HP TABLE-TOP STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

ForPro

FDA UDI
Tng Worldwide, Inc.·00672047000246·Vinyl Exam Gloves SIze X-Large 100ct

KIRSCHNER AND GUIDE WIRES

FDA 510(k)
FDA Class 2 ·Orthopedic

VAXCEL PLUS CHRONIC DIALYSIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

M2A-MAGNUM MODULAR HEAD SZ 46MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 15, 2011

TECNIS CL

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·October 3, 2014

CAMERA COVER ADAPTOR FOR STRYKER VISIUM LED

FDA Adverse Event
Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code FTA·February 21, 2018

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013