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