97 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973646·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973561·
Lyophilized Platelets
FDA UDI
Bio/Data Corporation·G0561015951·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501736·Gutta Percha Points is used to root canal filin...
Portex
FDA UDI
ICU MEDICAL, INC.·15019517103458·
ZAVATION TAP
FDA UDI
Zavation LLC·00197157013301·TIGER 2 TAP, Ø 9.5mm, EXCELSIUSGPS CANNULATED
Portex
FDA UDI
ICU MEDICAL, INC.·15019517103465·
Portex
FDA UDI
ICU MEDICAL, INC.·15019517103441·
ECLERIS MICROSTAR COLPOSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090; 4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070; 5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080; 6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090; 7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070; 8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080; 9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090; 10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070; 11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080; 12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 18, 2024
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 27, 2026
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 1, 2013
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 19, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 25, 2011
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 19, 2026
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026