15 results · 21ms · Sources: EU EUDAMED, US FDA

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Powder Free Blue Nitrile Examination Glove

FDA 510(k)
FDA Class 1 ·General Hospital

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106471·MANHATTAN E & E SUTURE FCPS W/ PLATFORM

Midmark

FDA UDI
MIDMARK CORPORATION·00841709108945·The Midmark UltraComfort Concept LR Dental Chai...

FORMATK MAGMA PLATFORM LASER

FDA Adverse Event
Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

CENTURION PRESSURE INJECTABLE EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

ZIMMER COLLAGEN REPAIR PATCH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ACUVUE MOIST

FDA Adverse Event
Injury ·JOHNSON AND JOHNSON VISION CARE, INC.·Product code LPL·August 23, 2022

SOLID SCREWDRIVER, SMALL

FDA Adverse Event
Malfunction ·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021

FORMATK MAGMA PLATFORM

FDA Adverse Event
Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

FORTIFY VR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·February 18, 2015

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

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