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MEDICAL PRECISION IMPLANTS, S.A.

Manufacturer
🇪🇸 Spain

DELPHOS IMPLANTS – Indústria, Comércio, Importação e Exportação de Implantes Médicos, S.A.

Manufacturer
🇵🇹 Portugal

External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.

FDA Recall
Terminated ·Integra LifeSciences Corp·Product code LID·December 16, 2002

NEURO BALLOON CATHETER 64CM

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES IMPLANT S.A.·Product code GWG·December 19, 2006

NEXGEN RHK FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code KRO·October 2, 2015

Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.

FDA Recall
Terminated ·Integra LifeSciences Corp.·Product code GCY·May 7, 2010

Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.

FDA Recall
Terminated ·Integra LifeSciences Corp.·Product code GYK·December 22, 2010

BestFit Implants S.A.

Importer
🇪🇸 Spain

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

FDA Enforcement
Class II ·Ongoing·SIN SISTEMA DE IMPLANTE NACIONAL S.A·January 22, 2025

FRONT-DENT Fogászati Termék Kereskedelmi Korlátolt Felelősségű Társaság

Importer
🇭🇺 Hungary·6 Manufacturers

Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.

FDA Recall
Terminated ·Boston Scientific CRM Corp·Product code KRG·July 22, 2010

MEDICAL PRECISION IMPLANTS, S.A.

Importer
🇪🇸 Spain

Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 CONTAK RENEWAL 4/4RF Models H190*, H195*, H197*, H199*, M170*, M175*, M177*, M179*, H230*, H235*, H239* *Not available in the US

FDA Recall
Terminated ·Boston Scientific CRM Corp·Product code LWP·July 22, 2010

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FDA Adverse Event
Injury ·ELEKTA IMPLANTS S.A.·Product code JXG·July 11, 1997

EXTERNAL DRAINAGE SET

FDA Adverse Event
Injury ·ELEKTA IMPLANTS S.A.·Product code JXG·January 16, 1998

HV LIMBAR VALVE SYS WHITE, TALL CHILD/ADULTS

FDA Adverse Event
Injury ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·February 21, 2012

PENA MUSCLE STIMULATOR PROBE

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code IPF·March 29, 2012

PENA MUSCLE STIMULATION PROBE

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code IPF·March 29, 2012

OSV II LOW PRO

FDA Adverse Event
Injury ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·March 16, 2012

PENA MUSCLE STIMULATOR PROBE

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code IPF·March 29, 2012