16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIC invent Dental Implant Systems
FDA 510(k)
FDA Class 2
·Dental
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JBAIDS Q FEVER DETECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·May 31, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 23, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·September 19, 2008
MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021
OLYMPUS ESG-100, 100...120 V~,
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 16/200
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 12, 2019
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 22/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 5, 2018
ALLOFIT-S ALLOCLAS SHELL 66/PP
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·September 5, 2018
REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 5, 2018
REVITAN®, DISTAL PART, CURVED, UNCEMENTED, 20/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWY·November 17, 2023
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019
Disposable Accessory Kit, 3-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