11 results · 30ms · Sources: EU EUDAMED, US FDA

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PROPHECY Preoperative Navigation Alignment System

FDA 510(k)
FDA Class 2 ·Orthopedic

Unicondylar Sled Prosthesis

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575359479·Tibia Plateau,all-polyethylene

GOLD CORE HF PRE SOLDER

FDA 510(k)
FDA Class 2 ·Dental

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX

FDA 510(k)
FDA Class 1 ·General Hospital

UNIVERSAL II

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQE·December 16, 2006

LIGAMAX CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 27, 2014

CELL-DYN 3200 SL 110V ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 11, 2011

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 2, 2013

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

FDA Recall
Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

FDA Enforcement
Class II ·Ongoing·Linkbio Corp.·May 10, 2023

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