15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIHARDS TITANIUM HALF PIN
FDA 510(k)
FDA Class 2
·Orthopedic
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200241·Mand. 1. Molar band W-Fit left 24
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110966·STERILIZING CASE 4-KNIVES
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200240101·Mand. 1. Molar band W-Fit left 24
Matching Limb Protection Sleeves - Easi-Fit
FDA UDI
Delfi Medical Innovations Inc·M995979200241·Delfi Matching Limb Protection Sleeves (MLPS) h...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200240501·Mand. 1. Molar band W-Fit left 24
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89200240051·Mand. 1. Molar band W-Fit left 24
Arthrex®
FDA UDI
ARTHREX, INC.·00888867058187·UNIVERS TRIAL STEM, 13MM
MECTALIF TRANSFORAMINAL
FDA 510(k)
FDA Class 2
·Orthopedic
CARIS MINITOME BIOPSY INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXIUM 3-D DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·January 17, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·December 3, 2010
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·July 8, 2014
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