15 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FINGER PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857554559·Trial Size 14x18x6 mm, Convex
Phadia Information Data Manager Software Package
FDA UDI
Phadia AB·07333066001012·Phadia Information Data Manager Software Package
K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
ADVIA Centaur® Cuvettes
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414221588·Laboratory analyser cuvette, IVD
HYPOTHERMX INTRAVENOUS FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 23, 2024
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 22, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 14, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·August 14, 2008
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026