11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CLINICAL DATA APNEA DETECTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217201·CUSTOM VEIN KIT
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217211·CUSTOM VEIN KIT
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
FDA 510(k)
FDA Class 2
·Ophthalmic
EQUALIZER BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 6, 2012
STRYKEFLOW2 WITHOUT TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GCX·August 25, 2010
CODMAN LUMBAR CATHETER KIT
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·June 19, 2013
CODMAN EXTERNAL DRAINAGE SYSTEM II
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·March 2, 2010
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026