11 results · 18ms · Sources: EU EUDAMED, US FDA

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BMC RIAFLO SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Leica Biosystems

FDA UDI
Leica Biosystems Richmond, Inc.·10849832012440·Frozen Section Compound 22, Blue, 4 fl. oz 118 mL

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209124732·KIT, FIRST AID & TRAUMA - CLASS A - HARD CASE w...

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET

FDA 510(k)
FDA Class 2 ·Dental

PALCERAM 49

FDA 510(k)
FDA Class 2 ·Dental

UNKNOWN IMPLANTABLE HARDWARE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·October 23, 2012

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·August 16, 2010

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

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