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

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URIHESIVE STRIPS

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

MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

FDA 510(k)
FDA Class 2 ·Cardiovascular

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·October 23, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·June 12, 2007

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS SLC·Product code JAA·December 30, 2013

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 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