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

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ARCHITECT CA 125 II ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809868180·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

3-Lead Leadset,Adt/Ped,AHA,Clip,Long

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004532·

N LATEX B2-MICROGLOBULIN

FDA 510(k)
FDA Class 2 ·Immunology

SOLO-CARE PLUS MULTIPURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

MEDTRONIC SYNCHROMED II

FDA Adverse Event
Injury ·Product code LKK·April 3, 2013

FINELINE II

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 6, 2011

DUO FLUID CART WITH SMOKE EVACUATOR

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·February 27, 2020

PKG, 5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM, P/N 0250080586 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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