11 results
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33ms
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Sources: EU EUDAMED, US FDA
LIGHT, HEAD, EXAMINATION
FDA 510(k)
FDA Class 1
·General Hospital
Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08052693623556·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.6
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083016630·STR, 10 electrode, MPD-DL, 2mm electrode spacing
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746111150·DB BKT MINI MS UL CUSP 018 T-7 A+7 R=0
QUATTRO PORCELAIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
WMT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THUNDERBEAT 5MM, 35CM, FRONT-ACUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEM CORP·Product code LFL·May 5, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 17, 2010
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
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017