261 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0160270·Driver Shaft, Universal Removal, T27
MODIFICATION TO XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CALIBRATING MATERIAL, BUFFERS, STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NITRILE GLOVES
FDA Adverse Event
Malfunction
·AMMEX CORPORATION·Product code LZA·June 16, 2025
OLYMPUS UROLOGY LASER FIBER WIRE
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 9, 2022
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 16, 2013
HYDROTHERMABLATOR PROCEDURE SET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MNB·June 13, 2008
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011
IHEALTH COVID-19 ANTIGEN RAPID TEST
FDA Adverse Event
Malfunction
·IHEALTH·Product code QKP·August 17, 2022
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
POWERLINE CV CATHETER, POLYURETHANE SINGLE-LUMEN, 5F
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·August 9, 2023
PTFE FELT PLEDGETS
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DXZ·May 3, 2023
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180 G01237 TSF-35-80 G00664 C-SF-25-30 G02163 C-SF-21-30 G02351 THSF-35-80 G02408
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·September 3, 2025