10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
Edge™ Diamond DC022-0.3mm Depth Cutter
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172007368·Diamond dental bur, reusable
BEYONDIMAGE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
AEON Laparoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOCRYL PLUS ANTIBACTERIAL SUTURES
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·March 7, 2013
CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·February 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017