11 results
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19ms
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Sources: EU EUDAMED, US FDA
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
FDA 510(k)
FDA Unclassified
·Unknown
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
FDA 510(k)
FDA Class 1
·General Hospital
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
MONARCH INFLATION SYRINGE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·March 18, 2011
VANDERLIFT 450
FDA Adverse Event
Other
·VANCARE, INC.·Product code FSA·June 16, 2008
CONSULT HCG URINE CASSETTE 5001 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·September 9, 2019
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Enforcement
Class II
·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015