21 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini-Taurus
FDA UDI
Rmo, Inc.·00885797100719·ALEX MT 022 W/O HK 5-5 20EA
KATENA
FDA UDI
KATENA PRODUCTS, INC.·00841668144473·Wide-Angle Viewing RS Lens
GLIDESHEATH SLENDER
FDA UDI
TERUMO MEDICAL CORPORATION·00389701012100·GLIDESHEATH SLENDER Stainless Steel Kit
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098032·Spinal Discectomy Retractor
Symmetry Williams
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031292·Symmetry® Retractor, Williams Microlumbar, 50 m...
ACUMED
FDA UDI
Acumed LLC·10806378050671·Drill/Wire Guide Assembly 17mm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209129515·
AERONEB GO NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
VMCore Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 9, 2014
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007
M2A MAGNUM SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 6, 2017
M2A MAGNUM SYSTEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 6, 2017
Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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