10 results
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35ms
·
Sources: EU EUDAMED, US FDA
RETRIEVABLE FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111093·SILICONE MAT FOR K 9-2340
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
FDA 510(k)
FDA Class 1
·Immunology
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2014
*
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code LRO·September 17, 2012
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015