14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUNTOUCH Dental Dressing
FDA 510(k)
FDA Unclassified
·Unknown
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MASTER-VU
FDA 510(k)
FDA Class 2
·Radiology
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024
STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 5, 2023
SLEEPSTYLE AUTO
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024
TIP, TIBIAL INSERT IMPACTOR
FDA Adverse Event
Malfunction
·CONFORMIS·Product code LXH·May 31, 2013
NOVATION CROWN CUP SHELL, CLUSTER-HOLE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 19, 2014
VENTAK PRIZM
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 12, 2026
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 29, 2012
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025