15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ventway Sparrow
FDA 510(k)
FDA Class 2
·Anesthesiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514018·
NA
FDA UDI
Synthes GmbH·10886982145277·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·October 27, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 2, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·May 28, 2023
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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