16 results
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30ms
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Sources: EU EUDAMED, US FDA
MYGAIT STIMULATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016781·RICHARDS PISTON 3.5MM LENGTH .4MM DIAMETER PLAT...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221038098·Unitek(TM) Bicuspid Band General Purpose Wide L...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321418120·
TALOS®-A
FDA UDI
SpineArt SA·07640375237699·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311418120·
ZAVATION
FDA UDI
Zavation LLC·00842166186835·14mm X 18mm 12° Trial
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G81711325141812·Osteotomy Wedge System, Cotton Trial 14W x 18D ...
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G817S111141812·Cotton Wedge, 14W x 18D x 12H
CONSTRUX MINI PEEK SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 9, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014