14 results · 21ms · Sources: EU EUDAMED, US FDA

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PLASTALGIN AND PLASTALGIN ORTHO

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032708·Baltic Denture System BDLoad Mm7 PLSEbim6DFm BL...

Cook

FDA UDI
COOK INCORPORATED·00827002170773·Silicone Universal Drainage Stent

ICU Medical

FDA UDI
ICU MEDICAL, INC.·00840619060053·TriOx™ SvO2 PA Catheter P7110-EP-H, 7.5F, 110cm...

Plateau-LO Spacer System

FDA UDI
Life Spine, Inc.·00190837027582·PLATEAU-LO Interbody, 10mm x 32mm x 8mm, 7°

K032008

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LJT·May 31, 2007

KAVO CORUND HANDPIECE 2013

FDA 510(k)
FDA Class 2 ·Dental

ELECTROPHYSIOLOGY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ESSURE

FDA Adverse Event
Malfunction ·CONCEPTUS INC.·Product code HHS·April 2, 2013

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·March 29, 2011

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 22, 2008

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024