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SunMed Holdings, LLC

18 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog recall (Z-1114-2026)SunMed Holdings, LLC2026-01-28
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog recall (Z-1115-2026)SunMed Holdings, LLC2026-01-28
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog recall (Z-1116-2026)SunMed Holdings, LLC2026-01-28
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Numbe recall (Z-1117-2026)SunMed Holdings, LLC2026-01-28
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife b recall (Z-1904-2025)SunMed Holdings, LLC2025-06-20
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 f recall (Z-1814-2025)SunMed Holdings, LLC2025-05-30
Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple acces recall (Z-0361-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory recall (Z-0362-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory co recall (Z-0363-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory c recall (Z-0364-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory c recall (Z-0365-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory recall (Z-0366-2024)SunMed Holdings, LLC2023-11-21
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory con recall (Z-0367-2024)SunMed Holdings, LLC2023-11-21
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations recall (Z-0368-2024)SunMed Holdings, LLC2023-11-21
Medline manual resuscitators with integrated manometer, multiple accessory configurations recall (Z-0369-2024)SunMed Holdings, LLC2023-11-21
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 recall (Z-1019-2023)SunMed Holdings, LLC2023-01-26
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 recall (Z-1020-2023)SunMed Holdings, LLC2023-01-26
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 recall (Z-1779-2022)SunMed Holdings, LLC2022-09-23

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Every clearance here is in the API, with alerts when new ones post.