13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POLYVAC INSTRUMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503492·TITANIUM FIXATION SCREW, KIT 20 PAIRS
Gladstone ALIF Trial Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215044923·
DENTURE BASE
FDA UDI
AMERICAN TOOTH INDUSTRIES·D72ATI0402230·DENTURE BASE ETHNIC SHADE 1-OZ LIQ&PWDR
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
FDA 510(k)
FDA Class 2
·Ophthalmic
SILKTOE SPACER
FDA Adverse Event
Injury
·BRM EXTREMITIES S.R.L.·Product code KWH·February 25, 2026
MULTI-RADIOFREQUENCY CABLE
FDA Adverse Event
Malfunction
·BAYLIS MEDICAL CO., INC.·Product code GXI·April 3, 2013
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 5, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·May 8, 2008
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016