13 results
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21ms
·
Sources: EU EUDAMED, US FDA
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
FDA 510(k)
FDA Class 2
·Anesthesiology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517175342·VuePoint Screw, 3.5x12mm Fav Angle Tulip
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113295·STAB KNIFE 30 DEGREE (BX/5)
STILLE Forceps
FDA UDI
Stille AB·07332339202026·ADSON-BROWN STILLE TISSUE FORCEPS side-grasping...
CC101 ECG MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PROTON VISION 7.0
FDA 510(k)
FDA Class 2
·Radiology
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·June 11, 2012
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 11, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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