15 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPLUS DENTAL IMPLANTS (HA)
FDA 510(k)
FDA Class 2
·Dental
Standard 64 Sublative iD, (20 Pulse), 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109952193·Standard 64 Sublative iD, (20 Pulse), 10-Pk
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
FDA 510(k)
FDA Class 2
·Ophthalmic
SMARTSTEP SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 27, 2011
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·October 21, 2020
KLS MARTIN
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 17, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
OXFORD UNICOMPARTMENTAL PHASE 3 LEFT MEDIAL TIBIAL TRAY STD SIZE D
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·April 29, 2011
RIATA ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
JOSTENT GRAFTMASTER
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 24, 2009
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·October 23, 2024
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·September 20, 2024
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012