12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MULTIX Impact
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517628596·CoRoent Ant TLIF Ti, 10x13x34mm 15°
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184353·Accufit Molar Bands Lower Right Second Molar 34...
Ophthalmic Spatulas
FDA UDI
KATENA PRODUCTS, INC.·00841668114322·RUBENSTEIN CORNEAL ROLLER (BX/3)
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
FDA 510(k)
FDA Class 2
·Anesthesiology
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
FLEXIMA ALL PURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFA·October 15, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 2, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021