24 results
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8ms
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Sources: EU EUDAMED, US FDA
Carina Sub-Acute Care Ventilator
FDA Enforcement
Class I
·Ongoing·Draeger Medical, Inc.·August 30, 2023
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·February 4, 2026
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·February 4, 2026
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·February 4, 2026
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·February 4, 2026
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·July 2, 2025
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
FDA Enforcement
Class I
·Ongoing·SunMed Holdings, LLC·June 11, 2025
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 28, 2014
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T GEN 2 Bibag without CDX
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. CDX BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. W/O CDX BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T Hemodialysis System without CDX
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
stay-safe /Luer Lock Adapter 4 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
stay-safe /Luer Lock Catheter Ext. 18 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
stay-safe /Safe Lock Catheter Ext. 12 in
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 3, 2024
2008T Hemodialysis System w/Bibag
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023