10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Pain Eraser
FDA 510(k)
FDA Unclassified
·Unknown
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
PUMP MMT-712NAP PRDGM INSULIN PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 7, 2008
NEUROFORM 3 EZ- 4.5 X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR CORK·Product code NJE·June 27, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·July 26, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; 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