16 results
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19ms
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Sources: EU EUDAMED, US FDA
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF
FDA 510(k)
FDA Class 1
·Physical Medicine
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006731·VITROS Chemistry Products VANC Reagent
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130344·
ACUMED
FDA UDI
Acumed LLC·10806378111921·Long Stem Reamer 9mm
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580170900001·SURE-SNAP 2. MOLAR UPR RGT SZ 09
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS AFP - ALPHA-FETOPROTEIN
FDA 510(k)
FDA Class 2
·Immunology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·February 11, 2014
5MM POSTERIOR 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
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LEH·October 12, 2005
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 3, 2017
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LEH·February 21, 2017
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