11 results · 33ms · Sources: EU EUDAMED, US FDA

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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