14 results
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28ms
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Sources: EU EUDAMED, US FDA
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