12 results · 35ms · Sources: EU EUDAMED, US FDA

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CENTRIFICHEM SYSTEM 500 ANALYZER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CAPIOX® Holders

FDA UDI
Terumo Cardiovascular Systems Corporation·00886799000571·Accessories for CAPIOX® Oxygenators, holder for...

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117246·

ACUMED

FDA UDI
Acumed LLC·10806378046940·3.5mm Flexible Drill Guide, Long

PROSTIVA RF THERAPY MODEL 8929 HAND PIECE

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

PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

FDA 510(k)
FDA Class 2 ·Cardiovascular

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 8, 2014

IMPLANT PDS3000M 6PK PILLAR PALATAL

FDA Adverse Event
Malfunction ·XOMED MFG JACKSONVILLE·Product code LRK·October 17, 2012

VASOVIEW HEMOPRO 2

FDA Adverse Event
Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 26, 2015

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