Medical Device Manufacturer · US , Mchenry , IL

Medela, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1980

Recent clearances: Medela Low Dose Enteral Syringe, Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail, MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

19
Total
19
Cleared
0
Denied

Medela, Inc. has 19 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 19 cleared submissions from 1980 to 2017. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Medela, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Tuv Product Service, Inc., Tuv America, Inc. and Pathway Regulatory Consulting, LLC.

FDA 510(k) Regulatory Record - Medela, Inc.

19 devices
1-19 of 19
Cleared Feb 15, 2017
Medela Low Dose Enteral Syringe
K161811 · PNR
Gastroenterology & Urology · 229d
Cleared Oct 28, 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing...
K161725 · HGX
Obstetrics & Gynecology · 128d
Cleared Jun 06, 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · HGX
Obstetrics & Gynecology · 14d
Cleared Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · HGX
Obstetrics & Gynecology · 16d
Cleared Apr 20, 1999
PHOTOTHERAPY LAMP
K984589 · LBI
General Hospital · 117d
Cleared Jan 07, 1999
BASIC, MEDIAN, DOMINANT, AND VARIO
K983552 · BTA
General & Plastic Surgery · 90d
Cleared Dec 12, 1996
BILIBED PHOTOTHERAPY LAMP
K962612 · LBI
General Hospital · 162d
Cleared Oct 16, 1995
MEDELAS BREAST PUMP
K950750 · HGX
Obstetrics & Gynecology · 241d
Cleared Sep 12, 1995
MEDELA'S FOOT PUMP
K952034 · HGY
Obstetrics & Gynecology · 134d
Cleared Jan 22, 1993
BREAST SHELLS
K923577 · HFS
General Hospital · 186d
Cleared Aug 06, 1990
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · HGX
Obstetrics & Gynecology · 137d
Cleared Apr 06, 1988
MEDELA BREAST-PUMP LACTINA
K875300 · HGX
Obstetrics & Gynecology · 99d
Cleared Aug 22, 1985
CANNON BABYSAFE NIPPLE SHIELDS
K853176 · HFS
General Hospital · 41d
Cleared Feb 25, 1985
SUPPLEMENTAL FEEDING SYSTEM
K844297 · HGY
Obstetrics & Gynecology · 119d
Cleared May 07, 1984
AB VACUUM EXTRACTOR SILC-CUP
K841492 · HDB
Obstetrics & Gynecology · 27d
Cleared Jan 10, 1984
MEDELA APGAR TIMER
K834129 · LHB
General Hospital · 41d
Cleared Jan 24, 1983
MEDELA NAMUAL BREAST PUMP
K823840 · HGY
Obstetrics & Gynecology · 34d
Cleared Jan 24, 1983
MEDELA SUCTION PUMP
K830012 · HDB
Obstetrics & Gynecology · 21d
Cleared Oct 23, 1980
MEDELA ELECTRIC BREAST PUMP
K801862 · HGX
Obstetrics & Gynecology · 79d
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