27 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040047613·Scaler DE 204 Hollow
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040012925·Zirlux 16+ D3 95X30
CERASMART®
FDA UDI
Gc America Inc.·D0470119551·CERASMART® Glidewell 14 A1 LT 5p Block
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361011187·PedFuse RespondX, CNL, 7.0mm x 55mm
BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·August 18, 2023
SHARPS CONTAINER
FDA Adverse Event
Malfunction
·Product code MMK·January 13, 2026
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 18, 2016
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DLZ·March 20, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·February 10, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 11, 2008
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007