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

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PERIO PROTECT TRAY

FDA 510(k)
FDA Class 1 ·Dental

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...

Battalion

FDA UDI
ALPHATEC SPINE, INC.·00840967187310·Battalion, LLIF Trial, 8°, 18 mm Wide, 09 mm X ...

V-2100G ADVANCED INFANT INCUBATOR

FDA 510(k)
FDA Class 2 ·General Hospital

D.SIGN 59

FDA 510(k)
FDA Class 2 ·Dental

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 19, 2018

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 12, 2026

PERCUTANEOUS INSERTION HANDLE FOR FEMORAL NAILS-EX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·April 2, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·March 21, 2011

DXTEND STAND PE CUP D42 + 6MM

FDA Adverse Event
Injury ·DEPUY FRANCE S.A.·Product code KWS·April 17, 2008

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

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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015