22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENTAKE STANDARD AND SAFETY PEG SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610211·
STRAIGHT PLATE, 21-HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665029086·
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610211·Mini Sprint-Brackets 5-5 Roth .022" 20 Brackets...
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0160210·Currette, Reverse Angle, #5
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
FDA 510(k)
FDA Class 2
·Cardiovascular
LASER 20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013
ST JOSEPHS PHOENIX, AZ 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code DWF·July 31, 2009
RU NOVOSIBRIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·October 16, 2013
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 26, 2013
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Other
·DEXCOM, INC.·Product code MDS·March 23, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·June 12, 2008
CP87641 GB SOUTHAMPTON
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·March 22, 2010
D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017
PIVO Blood Collection Device 20G, REF: 202-0005
FDA Enforcement
Class II
·Terminated·Velano Vascular·February 2, 2022
Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013
cobas 8000 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