16 results · 21ms · Sources: EU EUDAMED, 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