7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
PATIENT GUIDED KNEE EXERCISER
FDA 510(k)
FDA Class 1
·Physical Medicine
SignosRT Bladder Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
FUSION PUTTY TYPE
FDA 510(k)
FDA Class 2
·Dental
EXTENSION SET WITH T-CONN.SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·March 14, 2014
EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·November 19, 2012
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2010
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
FDA Recall
Terminated
·Hamilton Co·Product code JJE·September 26, 2011