Medela, Inc. is one of 6936 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medela, Inc. - FDA 510(k) Cleared Devices
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
Cleared
Feb 15, 2017
Medela Low Dose Enteral Syringe
Gastroenterology & Urology
229d
Cleared
Oct 28, 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing...
Obstetrics & Gynecology
128d
Cleared
Jun 06, 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
Obstetrics & Gynecology
14d
Cleared
Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
Obstetrics & Gynecology
16d
Cleared
Apr 20, 1999
PHOTOTHERAPY LAMP
General Hospital
117d
Cleared
Jan 07, 1999
BASIC, MEDIAN, DOMINANT, AND VARIO
General & Plastic Surgery
90d
Cleared
Dec 12, 1996
BILIBED PHOTOTHERAPY LAMP
General Hospital
162d
Cleared
Oct 16, 1995
MEDELAS BREAST PUMP
Obstetrics & Gynecology
241d
Cleared
Sep 12, 1995
MEDELA'S FOOT PUMP
Obstetrics & Gynecology
134d
Cleared
Jan 22, 1993
BREAST SHELLS
General Hospital
186d
Cleared
Aug 06, 1990
MEDELA BATTERY OPERATED BREAST PUMP
Obstetrics & Gynecology
137d
Cleared
Apr 06, 1988
MEDELA BREAST-PUMP LACTINA
Obstetrics & Gynecology
99d