13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEEDLE-TRAP/NEEDLE SAFETY LABEL
FDA 510(k)
FDA Class 2
·General Hospital
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT APOLIPOPROTEIN B VER.2
FDA 510(k)
FDA Class 2
·Immunology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 26, 2024
BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·August 3, 2022
OLYMPUS ESG-100, 100...120 V~,
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 29, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008
METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676
FDA Recall
Terminated
·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006
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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024