615 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
PINPOINT Endoscopic Fluorescence Imaging System
FDA Enforcement
Class II
·Terminated·Novadaq Technologies Inc.·March 9, 2016
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
FDA Enforcement
Class III
·Terminated·Pega Medical Inc.·May 27, 2020
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
FDA Enforcement
Class II
·Terminated·Amd Ritmed·April 6, 2016
Zimmer Biomet Canada DFE
FDA registration
Zimmer Biomet Canada DFE·20 products·🇨🇦 Canada
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
MedMira Laboratories Inc.
Manufacturer
🇨🇦 Canada·6 Basic UDI-DIs·6 Devices·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS
OrthoPediatrics Canada ULC
Manufacturer
🇨🇦 Canada·143 Basic UDI-DIs·143 Devices·1 Importer
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiple Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
The Locking Pediatric Osteotomy Plate system
Device
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·On the market·1 country
The GAP Nail Endo-Exo Medullary System
Device
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·On the market·1 country
The Hinge Pediatric Plating System
Device
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·On the market·1 country
The Hinge Pediatric Plating System
Device
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·On the market·1 country
Dr Paley’s Osteotomy System
Device
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·On the market·1 country