13 results
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24ms
·
Sources: EU EUDAMED, US FDA
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
FDA 510(k)
FDA Class 2
·Cardiovascular
Portex
FDA UDI
ICU MEDICAL, INC.·15019517074000·
REUSABLE GUIDE
FDA 510(k)
FDA Class 2
·Radiology
ALCOMATE, MODEL CA2000
FDA 510(k)
FDA Class 1
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 12, 2024
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 13, 2024
UNKNOWN MESH PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code FTL·November 10, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·September 2, 2011
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 22, 2013
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020