14 results
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22ms
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Sources: EU EUDAMED, US FDA
EYEWI ANKORS
FDA 510(k)
FDA Class 1
·General Hospital
MGB Alert® BKV ASR v3.0 Primer Mix, 48 reactions
FDA UDI
Elitechgroup Mdx LLC·03661540952340·MGB Alert® BK Virus ASR v3.0 Probe Mix contains...
DSQ Alert BK Virus v3.0 Primer Mix
FDA UDI
Elitechgroup Mdx LLC·03661540952746·DSQ Alert BK Virus ASR v3.0 Primer Mix contains...
Endo-Model Saddle Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575047840·Setscrews
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742103129·ADARA ø4.5mm Cortical Screw, Full Thread, Self-...
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CALYPSO 4D LOCALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012
EON MINI 16-CHANNEL IPG
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 12, 2010
LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·December 14, 2011
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code FMI·February 1, 2013
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code FMI·April 2, 2012
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023