12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bosworth TruRepair
FDA UDI
Harry J Bosworth Company·H6680921621·3 oz Repair Pwd, Vein
NA
FDA UDI
STERILMED, INC.·10888551021302·BUR DIAMOND ROUND
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2020
*
FDA Adverse Event
Malfunction
·OLYMPUS CORPORATION OF THE AMERICAS·Product code FGB·April 8, 2014
MORPHEUS SMART PICC
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code LJS·April 30, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 27, 2011
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 2120 (21-2120, 21-2125, and 21-2127) 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