16 results
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36ms
·
Sources: EU EUDAMED, US FDA
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
FDA 510(k)
FDA Class 1
·Physical Medicine
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006724·VITROS Chemistry Products Calibrator Kit 24
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208017080·RETRACTOR, ALL TYPES
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551201978·Retractor, 70 x 14 mm, 21.5 cm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209131273·
ACUMED
FDA UDI
Acumed LLC·10806378051098·Long Stem Reamer 8mm
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580170800001·SURE-SNAP 2. MOLAR UPR RGT SZ 08
PROFOX SOFTWARE, MODEL 920M-41
FDA 510(k)
FDA Class 2
·Cardiovascular
TAXI ENDOSCOPIC GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·February 11, 2014
5MM DISTAL FEMORAL AUGMENT, SIZE: F
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007
BD PHASEAL¿ OPTIMA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FOZ·October 16, 2018
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIT·October 27, 2011
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