Medela, Inc.
Medela, Inc. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2017, with 4 FDA device recalls on record.
Top product codes for Medela, Inc.
FDA recalls by Medela, Inc.
- Z-2645-2026 — Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A
- Z-0773-2020 — Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).
- Z-2061-2019 — Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
- Z-2528-2018 — Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medela, Inc.
- K161811 — Medela Low Dose Enteral Syringe
- K161725 — Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
- K031614 — MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
- K020518 — MEDELA SYMPHONY BREAST PUMP, MODEL 024
- K984589 — PHOTOTHERAPY LAMP
- K983552 — BASIC, MEDIAN, DOMINANT, AND VARIO
- K962612 — BILIBED PHOTOTHERAPY LAMP
- K950750 — MEDELAS BREAST PUMP
- K952034 — MEDELA'S FOOT PUMP
- K923577 — BREAST SHELLS
- K901344 — MEDELA BATTERY OPERATED BREAST PUMP
- K875300 — MEDELA BREAST-PUMP LACTINA
- K853176 — CANNON BABYSAFE NIPPLE SHIELDS
- K844297 — SUPPLEMENTAL FEEDING SYSTEM
- K841492 — AB VACUUM EXTRACTOR SILC-CUP
- K834129 — MEDELA APGAR TIMER
- K823840 — MEDELA NAMUAL BREAST PUMP
- K830012 — MEDELA SUCTION PUMP
- K801862 — MEDELA ELECTRIC BREAST PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.