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

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ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES

FDA 510(k)
FDA Class 2 ·Dental

Hillrom™

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975835·Trumpf Medical/Medizin Pad seat section H G

Pads

FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968745·Pad seat section H G

TruForm

FDA UDI
Rmo, Inc.·00885797100009·MN 1MOL BD KT STD N/L UNIV 176

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN

FDA 510(k)
FDA Class 2 ·Microbiology

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 19, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

LIGHTSPEED VCT

FDA Adverse Event
Injury ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018