11 results
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18ms
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Sources: EU EUDAMED, US FDA
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