12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL FLUID TOTAL PROTEIN CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LOGIQ S8
FDA 510(k)
FDA Class 2
·Radiology
FLOEY CATHETER W TEMP
FDA Adverse Event
Injury
·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
UNKNOWN DEPUY AGILITY SZ 3 ANKLE INSERT
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code HSH·November 14, 2012
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2015
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024