15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zimmer Knee Joint Replacement Prostheses MR Labeling
FDA 510(k)
FDA Class 2
·Orthopedic
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
CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032568865684·SPACER NAIL 14 MM
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·July 23, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 30, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016
ASAHI CONFIANZA PRO 8-20
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016
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