Medical Device Manufacturer · US , Mchenry , IL

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

19 submissions · 19 cleared · Since 1980

Total

Cleared

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.

Medela, Inc. is one of 4733 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

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

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

Filters