Atlas FDA

Medela Inc

11 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Medela Inc

RecordFirmDate
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: recall (Z-2645-2026)Medela Inc2026-07-01
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressu recall (Z-2528-2018)Medela Inc2018-07-23
Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, Mc recall (Z-3172-2011)Medela Inc2011-09-08
Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact n recall (Z-2553-2011)Medela Inc2011-06-10
AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advan recall (Z-2386-2011)Medela Inc2011-05-27
Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breas recall (Z-1224-2011)Medela Inc2011-02-11
Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the recall (Z-2483-2010)Medela Inc2010-09-24
Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breas recall (Z-2484-2010)Medela Inc2010-09-24
Sterile single/double breast personal accessory convenience kit for single or double pumpi recall (Z-2485-2010)Medela Inc2010-09-24
Sterile single/double breast personal accessory convenience kit for the Lactina Breast pum recall (Z-2486-2010)Medela Inc2010-09-24
Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corp recall (Z-1442-2010)Medela Inc2010-04-27

Track Medela Inc automatically

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