18 results
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21ms
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Sources: EU EUDAMED, US FDA
SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
FDA 510(k)
FDA Class 2
·Neurology
Bur PM2-70 80K diamond extra coarse Ø6.0mm sterile
FDA UDI
Bien-Air Surgery SA·J00711003820011·
Bur PM2-70 80K Diam EC Ø6.0 St
FDA UDI
Bien-Air Surgery SA·17630055503487·
STAINLESS STEEL BRAIDED PRO FORM™ ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707066512·.016 X .022 Upper Stainless Steel Braided Pro F...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450124611·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332601·IN-OVATION® C Roncone 022 UL/3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100332101·IN-OVATION® C Base Rx 022 UL/3-3 CS HK
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
FDA 510(k)
FDA Class 2
·Anesthesiology
SALVIN DENTAL SPECIALTIES FIXATION SCREW
FDA 510(k)
FDA Class 2
·Dental
TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/9MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code JEY·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020