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

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ITE HEARING AID MODEL PALOMINO

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

Synergy

FDA UDI
Rmo, Inc.·00885797100948·DOLICH SY 185 HK MX/3 5-5 20EA

Family Wellness

FDA UDI
Family Dollar Stores·00032251058202·Extra Large Flexible Fabric Adhesive Bandages, ...

REGIONAL INTRAVENOUS ANESTHESIA KIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CER OPTION TYPE 1 TPR SLEVE +3

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 9, 2018

CER BIOLOXD OPTION HD 28MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 9, 2018

G7 DUAL MOBILITY LINER 46MM G

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 9, 2018

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·January 8, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 11, 2010

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

FDA Enforcement
Class II ·Completed·Cook Incorporated·July 20, 2022

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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