12 results · 27ms · Sources: EU EUDAMED, US FDA

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PET-DOSE

FDA 510(k)
FDA Class 2 ·Radiology

HairCheck-DT (PCP)

FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809868302·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

ICE BATON

FDA 510(k)
FDA Unclassified ·Unknown

VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·April 9, 2013

SYNCHRON UNICEL DXC 600PRO CLINICAL SYSTEMS

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

ENDOTAK ENDURANCE RX

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

OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

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