16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Surn5 Electrosurgical Argon Beam Generator and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113899·VISCO INJECTION CANNULA 26GA
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197407·Smooth Shank Poly. Screw, 3.5mm x 22mm
SALUTE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Gibralt®
FDA UDI
INNO Holdings, Inc.·M711050002035220·Posterior Cervical Screw Assembly, 3.5mm X 22mm...
Gibralt
FDA UDI
Choice Spine, LP·10885862145024·
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2024
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
T-SLING
FDA Adverse Event
Injury
·HERNIAMESH S.R.L.·Product code PAH·October 20, 2014
STERRAD 100NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 3, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025