19 results · 20ms · Sources: EU EUDAMED, US FDA

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RINGLOC CONSTRAINED LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

Safco FG Diamonds

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310216613·FG Diamond 862-014 flame regular 5/pack

UNITY IS PATIENT VIEWER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONCORD 88

FDA 510(k)
FDA Class 2 ·Dental

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·January 10, 2019

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 2, 2018

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·June 13, 2018

BRYAN CERVICAL DISC SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code MJO·March 26, 2013

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 21, 2011

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·March 18, 2008

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·March 31, 2018

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 28, 2018

EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·March 14, 2024

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 2, 2014

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWQ·August 22, 2017

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 9, 2020

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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014