12 results
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35ms
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Sources: EU EUDAMED, US FDA
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