17 results
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20ms
·
Sources: EU EUDAMED, US FDA
HEMORRHOIDAL LIGATION INSTR. SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00852979003175·Vukich Cartridge Loading Fcps
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776114312·Hardy Bivalve Specula
Symmetry Hardy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030769·Symmetry® Speculum, Hardy Bivalve, 80 mm
PROFILE MULTI-PLATFORM SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
KONG-C VBR M, Body, 52 mm
FDA UDI
icotec AG·07640164849867·KONG-C VBR M, Body, 52 mm
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 8, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 23, 2012
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·August 16, 2010
SYRINGE 20ML LL NS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 27, 2019
ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025
ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025
ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025
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