FDA 510(k) Applications Submitted by Medela AG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130123 |
01/17/2013 |
BASIC AND DOMINANT FLEX SUCTION PUMPS |
MEDELA AG |
| K141926 |
07/16/2014 |
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
| K113678 |
12/14/2011 |
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
| K080212 |
01/29/2008 |
MEDELA THOPAZ, MODEL 200 0288 |
MEDELA AG |
| K080357 |
02/11/2008 |
MEDELA INVIA WOUND THERAPY |
MEDELA AG |
| K180415 |
02/15/2018 |
Invia White Foam NPWT |
Medela AG |
| K172145 |
07/17/2017 |
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion û 120 days, Invia Motion û 60 days, Invia Motion û 30 days, Invia Motion û 15 days, Invia Motion û 7 days), Invia Liberty Negati |
Medela AG |
| K191653 |
06/20/2019 |
Freestyle Flex |
Medela AG |
| K182191 |
08/13/2018 |
Invia Abdominal Dressing Kit |
Medela AG |
| K223388 |
11/07/2022 |
Invia« Integrated Dressing |
Medela AG |
| K130210 |
01/29/2013 |
MEDELA THOPAZ |
MEDELA AG |
| K161128 |
04/21/2016 |
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 |
Medela AG |
| K153663 |
12/21/2015 |
Vario 8/18/ci |
MEDELA AG |
| K214112 |
12/30/2021 |
Invia Ease Negative Pressure Wound Therapy (NPWT) System |
Medela AG |
| K150134 |
01/21/2015 |
Basic, Dominant Flex, KV-6 |
MEDELA AG |
| K150499 |
02/26/2015 |
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty |
MEDELA AG |
| K151261 |
05/12/2015 |
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large |
Medela AG |
| K141553 |
06/11/2014 |
MEDELA THOPAZ+ |
MEDELA AG |
| K151632 |
06/17/2015 |
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 |
MEDELA AG |
| K021368 |
04/30/2002 |
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 |
MEDELA AG |
| K053052 |
10/31/2005 |
MEDELA SWING BREAST PUMP |
MEDELA AG |
| K061205 |
05/01/2006 |
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR |
MEDELA AG |
| K061435 |
05/24/2006 |
MEDELA VARIO SUCTION PUMPS |
MEDELA AG |
| K041579 |
06/14/2004 |
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 |
MEDELA AG |
| K033179 |
10/01/2003 |
MEDELA CLARIO HOME CARE PUMP |
MEDELA AG |
| K063336 |
11/06/2006 |
MEDELA DOMINANT 50 LIPO, MODEL 600-5706 |
MEDELA AG |
| K043544 |
12/23/2004 |
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR |
MEDELA AG |
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