Data / Medical devices / Switzerland / Medela AG
Medela AG: FDA-registered device maker in BAAR Zug, Switzerland, 39 510(k) clearances
Medela AG is registered with the FDA (registration 3002807523) in BAAR Zug, Switzerland. It lists 14 device types. The FDA files 39 510(k) clearances under its listings, the newest dated September 18, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807523
- Address
- Laettichstrasse 4B, BAAR Zug, Switzerland, CH-6340
- Owner or operator
- MEDELA AG (8030974)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- July 25, 2003
- Registered through
- 2026
- Brand names listed
- Basic & Dominant Flex, KV-6, Basic & Dominant Flex, KV-6 Suction Pumps, CALMITA, Freestyle, Freestyle Flex, Invia Abdominal Dressing Kit, Invia Foam Dressing Kit with FitPad Negative Pressure Wound Therapy System, Invia Gauze Dressing Kit with FitPad Negative Pressure Wound Dressing Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Breast Pump Kit | OHH | 2 | Manufacturer | accessdata.fda.gov |
| Extractor, Vacuum, Fetal | HDB | 2 | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Nipple, Lambs Feeding | FNN | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Manufacturer | accessdata.fda.gov |
| Timer, Apgar | LHB | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Neonatal Phototherapy | LBI | 2 | Manufacturer | accessdata.fda.gov |
| Utensil, Eating | ILC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2025 | K251377 | Magic InBra | HGX | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| July 7, 2023 | K223388 | Invia® Integrated Dressing | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| August 11, 2021 | K210759 | Solo, Swing Maxi | HGX | Substantially Equivalent | Medela, LLC | accessdata.fda.gov |
| October 17, 2019 | K191653 | Freestyle Flex | HGX | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| February 1, 2019 | K182191 | Invia Abdominal Dressing Kit | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| November 2, 2018 | K180415 | Invia White Foam NPWT | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| May 9, 2018 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| April 6, 2017 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| March 24, 2017 | K170329 | Basic, Dominant Flex | QPB | Substantially Equivalent | Modela AG | accessdata.fda.gov |
| December 1, 2016 | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| May 18, 2016 | K153663 | Vario 8/18/ci | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| November 5, 2015 | K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | HGX | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| June 12, 2015 | K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| April 21, 2015 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | HGX | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| April 21, 2015 | K150134 | Basic, Dominant Flex, KV-6 | QPB | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| August 25, 2014 | K141553 | MEDELA THOPAZ+ | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| October 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| March 15, 2013 | K130210 | MEDELA THOPAZ | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| October 1, 2012 | K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| July 24, 2008 | K080357 | MEDELA INVIA WOUND THERAPY | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| July 23, 2008 | K080212 | MEDELA THOPAZ, MODEL 200 0288 | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| February 26, 2007 | K063336 | MEDELA DOMINANT 50 LIPO, MODEL 600-5706 | QPB | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| June 21, 2006 | K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| June 8, 2006 | K061435 | MEDELA VARIO SUCTION PUMPS | OMP | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| April 21, 2005 | K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | HDB | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| January 7, 2005 | K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| October 15, 2003 | K033179 | MEDELA CLARIO HOME CARE PUMP | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| May 15, 2002 | K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| March 7, 2002 | K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | HGX | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| April 20, 1999 | K984589 | PHOTOTHERAPY LAMP | LBI | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| December 12, 1996 | K962612 | BILIBED PHOTOTHERAPY LAMP | LBI | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| January 22, 1993 | K923577 | BREAST SHELLS | HFS | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| August 6, 1990 | K901344 | MEDELA BATTERY OPERATED BREAST PUMP | HGX | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| April 6, 1988 | K875300 | MEDELA BREAST-PUMP LACTINA | HGX | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| August 22, 1985 | K853176 | CANNON BABYSAFE NIPPLE SHIELDS | HFS | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| May 7, 1984 | K841492 | AB VACUUM EXTRACTOR SILC-CUP | HDB | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| January 10, 1984 | K834129 | MEDELA APGAR TIMER | LHB | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| January 24, 1983 | K830012 | MEDELA SUCTION PUMP | HDB | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
| October 23, 1980 | K801862 | MEDELA ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Medela, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 2, 2020 | 87551 | Class II | Terminated | Stryker Medela REF AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump. | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Mesh, Surgical, Polymeric
- All makers of Unit, Neonatal Phototherapy
- All makers of Pump, Breast, Powered
- All makers of Extractor, Vacuum, Fetal
Updated September 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.