11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER BIOZIP SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SONICATOR PLUS 930, MODEL ME 930
FDA 510(k)
FDA Class 2
·Physical Medicine
MAGNETIC CONCERTO
FDA 510(k)
FDA Class 2
·Radiology
SQ-RX PULSE GENERATOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 10, 2024
THE Q-TRAK SUBCUTANEOUS ELECTRODE
FDA Adverse Event
Injury
·OSCOR INC·Product code LWS·June 10, 2024
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·February 27, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·April 4, 2008
UNKNOWN POLYSORB SUTURE
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GAM·March 20, 2023
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 VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024