18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANATOMICAL SHOULDER INVERSE/REVERSE
FDA 510(k)
FDA Class 2
·Orthopedic
ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSD·November 21, 2018
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWT·November 21, 2018
ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWS·November 21, 2018
LPC-PLUS ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 11, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
RUSCH
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCW·May 9, 2008
NEEDLE NS 25GA 3/4IN W/O SILICONE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·December 20, 2024
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 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
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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