10,000 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Instrusafe
FDA UDI
Summit Medical, Inc.·00385640008266·
Instrusafe
FDA UDI
Summit Medical, Inc.·00385640008372·
Instrusafe
FDA UDI
Summit Medical, Inc.·00385640008143·
SARA 3000
FDA Adverse Event
Injury
·MEDIBO N.V.·Product code FSA·April 20, 2005
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·October 29, 2021
MANUAL FREESTYLE BED W/ HALF RAILS
FDA Adverse Event
Death
·SUNRISE MEDICAL CCG·Product code FNJ·May 24, 2000
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
FDA Adverse Event
Death
·COOK INC·Product code JOH·March 14, 2022
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code JOH·March 25, 2025
BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
FDA Adverse Event
Injury
·COOK INC·Product code JOH·January 24, 2022
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·April 7, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
FDA Enforcement
Class I
·Ongoing·Cook Incorporated·May 17, 2023
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
FDA Enforcement
Class I
·Ongoing·Cook Incorporated·May 17, 2023
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·March 5, 2026
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
FDA Recall
Open, Classified
·Cook Incorporated·Product code JOH·April 7, 2023
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·April 15, 2026
Blue Rhino
FDA UDI
COOK INCORPORATED·00827002576827·Blue Rhino G2-Multi Percutaneous Tracheostomy I...
Blue Rhino
FDA UDI
COOK INCORPORATED·00827002577077·Blue Rhino G2-Multi Percutaneous Tracheostomy I...
Blue Rhino
FDA UDI
COOK INCORPORATED·00827002577039·Blue Rhino G2-Multi Percutaneous Tracheostomy I...