13 results · 28ms · Sources: EU EUDAMED, US FDA

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MENTOR ARIS SUPRAPUBIC SURGICAL KIT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Premier K-FILES

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053296·FILES PKG 6 31MM 30

BIOMET SCK KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MOSS MIAMI SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

RAD-5 PULSE OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

HOURGLASS

FDA Adverse Event
Injury ·MEDTRONIC·Product code MQP·June 16, 2014

RAD-8

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·February 4, 2016

ENERGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

3DKNEE SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSH·May 28, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

OXYSURE

FDA Adverse Event
Injury ·OXYSURE·Product code CAW·March 19, 2014

OXYSURE

FDA Adverse Event
Injury ·OXYSURE·Product code DQA·March 19, 2014

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