9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
FDA 510(k)
FDA Class 1
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM
ACUMED
FDA UDI
Acumed LLC·10806378091209·1.3/2.7mm Double Drill Sleeve
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
REGEN COLLAGEN SCAFFOLD (CS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 23, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021