505 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021942·SelectAir Cover w/foot pillow 60x84x10
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365022048·SelectAir Standard Cover w/Footpillow 36x84x8
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365022031·SelectAir Short Cover w/Footpillow 36x79x8
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021850·SelectAir Cover w/foot pillow 39x84x10
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021843·SelectAir Cover 2-piece cover w/foot pillow 36x...
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021904·SelectAir Cover w/foot pillow 48x84x10
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021928·SelectAir Cover w/foot pillow 54x84x10
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021874·SelectAir Cover w/foot pillow 42x84x10
SelectAir
FDA UDI
MOXI ENTERPRISES, LLC·00817365021997·SelectAir Standard Cover No Footpillow 36x80x8
SOF® TOURNIQUET NH, COLOR - BLUE
FDA UDI
TACTICAL MEDICAL SOLUTIONS, LLC·00818630012214·Among tourniquet brands, the SOF® Tactical Tour...
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code PJS·November 28, 2023
CLINITEK STATUS
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code KQO·April 17, 2015
ENTERRA II IPG
FDA Adverse Event
Malfunction
·ENTERRA MEDICAL, INC.·Product code LNQ·September 11, 2025
T-HANDLE
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code NHT·September 29, 2021
MEDIUM RATCHETING DRIVER HANDLE
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·May 6, 2022
1.5MM CANN. QUICK RELEASE DRIVER TIP
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code LXH·May 6, 2022
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.
FDA Recall
Terminated
·Biofire Defense·Product code NHT·August 13, 2014
Assay, Nucleic Acid Amplification, Bacillus Anthracis
FDA classification
FDA Class 2
·Assay, Nucleic Acid Amplification, Bacillus Anthracis
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
FDA Enforcement
Class II
·Ongoing·NuVasive Inc·August 3, 2022
Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L
FDA Recall
Open, Classified
·NuVasive Inc·Product code MJO·June 20, 2022