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

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MOSS MIAMI SPINAL SYSTEM PIN NUT

FDA 510(k)
FDA Class 2 ·Orthopedic

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOCRATES ROBOTIC TELEMONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 4, 2019

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·May 17, 2019

EASYPUMP: 100 ML, 2 ML/HR

FDA Adverse Event
Injury ·I-FLOW CORP.·Product code MEB·March 26, 2013

SEVEN CONTINOUS GLUCOSE MONITORING SENSOR

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code MDS·March 9, 2011

3 X 3 DUREPAIR DURA SUBSTITUTE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code GXQ·April 2, 2008

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·May 29, 2019

Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.

FDA Recall
Terminated ·Misys Healthcare Systems·Product code JQP·July 21, 2003

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

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018