12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Canada
×
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
AC Powered hospital adjustable bed.
FDA Enforcement
Class II
·Terminated·Umano Medical, Inc.·June 10, 2020
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·November 30, 2022
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Enforcement
Class II
·Terminated·MY01, INC.·September 8, 2021
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·November 13, 2019
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·April 8, 2020
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
FDA Enforcement
Class II
·Terminated·Epocal Inc·July 25, 2012
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
FDA Enforcement
Class II
·Terminated·Synaptive Medical, Inc.·December 30, 2015
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
FDA Enforcement
Class II
·Terminated·Baylis Medical Company Inc.·March 6, 2013
Baylis Medical Company Inc.
Manufacturer
🇨🇦 Canada·1 Importer
CUTTING WHEEL
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·1 device
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
FDA Enforcement
Class II
·Terminated·Mckesson Medical Imaging Group·August 29, 2012