13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ET II BIO-SA FIXTURE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
APEX™
FDA UDI
B. BRAUN MEDICAL INC.·04046964539220·EVA Single-Chamber Final Containers 3000 mL
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
SEPRAGEL SINUS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SENSOR BSA
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·May 14, 2013
VISTA BRITE TIP GUIDING CATHETERS
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·June 3, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
SMR CEMENTLESS MINI STEM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·January 21, 2020
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024