139 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·April 22, 2015
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
FDA Enforcement
Class II
·Terminated·NOBEL BIOCARE SERVICES AG·August 26, 2020
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
FDA Recall
Terminated
·NOBEL BIOCARE SERVICES AG Balz-zimmermannstrasse 7 Kloten Switzerland·Product code DZE·July 20, 2020
DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,
FDA Recall
Terminated
·Dignitana, Inc.·Product code PMC·November 5, 2021
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code DSI·November 12, 2019
CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code DSI·November 12, 2019
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code DSI·November 12, 2019
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·June 14, 2017
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code GDR·May 11, 2017