74 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fingertip Pulse Oximeter MD300CN310
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517731661·CoRoent XL+, 15x18x60mm 15°
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122261·Kwire .062x6" (1.6x150mm) Threaded
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122278·KWire .062x6" (1.6x150mm)
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108154·CASTROVIEJO NEEDLE HOLDER STR W/ LOCK
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047302·PrimaLIF LLIF PEEK Implant, 15mm X 22mm X 60mm,...
SONOMARK
FDA 510(k)
FDA Class 2
·Radiology
MEDLINE RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
STERIS
FDA Adverse Event
Malfunction
·VILEX·Product code HTY·April 6, 2005
UNOMETER SAFETI PLUS - WITH LEUR-LOCK AND LUER
FDA Adverse Event
Malfunction
·UNOMEDICAL LTD.·Product code EXR·January 2, 2015
UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
FDA Adverse Event
Malfunction
·UNOMEDICAL LTD.·Product code EXR·January 2, 2015
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
CRE BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KNQ·September 15, 2008
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 12, 2023
QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 23, 2020
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025