12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANNABINOID URINE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
Liofilchem Mic Test Strip (MTS)
FDA UDI
LIOFILCHEM SRL·08055182873043·The MTS™ Tetracycline 0.016-256 μg/mL is a quan...
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MILLENNIUM 5000 MEUROVASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·August 19, 2025
BIOMEX SHELL PC DIA48MM LN 22
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 2, 2015
TRACH CARE CLOSED SUCTION SYSTEM FOR NEONATES, 5 F, Y-ADAPTER
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK HEALTH CARE·Product code BSY·January 17, 2013
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DSI·December 13, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024