13 results · 22ms · Sources: EU EUDAMED, US FDA

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S2 NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032579·Baltic Denture System BDLoad ↓ Mm7 PLSEum2DFm D...

REPROCESSED PHACO TIPS

FDA 510(k)
FDA Class 2 ·Ophthalmic

DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013

LOW PROFILE CROSSLINK SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015

AIM

FDA Adverse Event
Other ·PHILIPS BURTON·Product code FQP·March 29, 2013

TI DISTAL EXTENSION

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code MDI·March 23, 2011

ELECSYS 2010 RACK

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 21, 2008

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013