11 results
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18ms
·
Sources: EU EUDAMED, US FDA
SALMONELLA FLAGELLAR A ANTIGEN & B
FDA 510(k)
FDA Class 2
·Microbiology
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031513·Rhoton® Curette, Micro, Angled, Size 14, 191 mm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131266·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776355081·R-Type Curette
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFE SCOPE P, MODEL BSM-4100 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2014
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 27, 2007
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