19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
FDA 510(k)
FDA Class 2
·General Hospital
Oticon
FDA UDI
Oticon A/S·05707131258830·H15, MINIRITE 312 WL CBE
DR COMFORT
FDA UDI
DJO, LLC·00888912235655·Sheer ThighHs OT W 20-30 Nude
Aileron Expandable Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000097·
Aileron Expandable Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000103·
ROCHE ONLINE TDM LIDOCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRANS1 AXIALIF PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
LOGIC CR TIB INSERT STD, SZ 5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 7, 2024
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·October 1, 2014
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 29, 2013
EYE STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 13, 2011
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024