10 results · 21ms · Sources: EU EUDAMED, US FDA

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THE AUTOTAC SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

artegral life

FDA UDI
Merz Dental GmbH·D7091993493·anteriors; shade D3; mould UBIM

ADVIA Centaur Total IgE (tIgE)

FDA 510(k)
FDA Class 2 ·Immunology

AESCULAP STERILCONTAINER S

FDA 510(k)
FDA Class 2 ·General Hospital

ROUND FILTER POLYPROVPYLENE

FDA Adverse Event
Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

SET SCREW, TI GAMMA3® Ø8X17.5MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·March 7, 2013

DUAL GEO.M/S SCREWLESS CUP 56MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDJ·February 8, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·August 8, 2014

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