12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LightForce LTS Model 1000, 1500, 2500, and 4000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
FDA 510(k)
FDA Class 2
·Dental
EXSALT SD7 WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
STEM EXTENSION
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023
STEMMED NONAUGMENTABLE TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023
LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022
6000CMS IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 30, 2013
LUCAS 2
FDA Adverse Event
PHYSIO-CONTROL·Product code DRM·July 11, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 13, 2022
INVISION¿ TOTAL ANKLE SYSTEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018