Medela L L C

FDA Filings

This page includes the latest FDA filings for Medela L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Medela L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MEDELA AG

FDA Registration(s)

• Registration Number: 1419937
• FEI Number: 1419937
• Name: MEDELA LLC
• Owner & Operator: MEDELA AG
• Contact Address: LAETTICHSTRASSE 4b --; BAAR CH-NOTA CH-6340 CH
• Official Correspondent:
  • Erhard J Huesler
  • 41-41-5621051-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1101 CORPORATE DR. ; MCHENRY, IL 60050 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K210759 Medela LLC	Solo, Swing Maxi	2021-08-11
PMN K200508 Medela LLC	Pump In Style	2020-06-15
PMN K181937 | HGX MEDELA LLC [MEDELA AG]	Advanced Personal Double Breastpump; Pump In Style Advanced	2018-11-06
PMN K181937 Medela LLC	Pump In Style Advanced, Advanced Personal Double Breastpump	2018-10-16
PMN K161811 | PNR MEDELA LLC [MEDELA AG]	Medela Low Dose Enteral Syringe	2017-09-19
PMN K161811 | FMF MEDELA LLC [MEDELA AG]	Medela Low Dose Enteral Syringe	2017-09-19
PMN K162188 | PNR MEDELA LLC [MEDELA AG]	Enteral Syringe with ENFit Connector	2017-07-20
PMN K161725 | HGX MEDELA LLC [MEDELA AG]	sonata	2016-11-15
PMN K161725 | HGX MEDELA LLC [MEDELA AG]	sonata warranty	2016-11-15
PMN K161725 | HGX MEDELA LLC [MEDELA AG]	sonata deluxe	2016-11-15
PMN K895367 | FPA MEDELA LLC [MEDELA AG]	Extension Set	2014-05-23
PMN K122449 | LGZ MEDELA LLC [MEDELA AG]	Guardian Warmer	2014-05-23
PMN K092986 | FMF MEDELA LLC [MEDELA AG]	Piston Syringe	2014-05-23
PMN K080328 | KNT MEDELA LLC [MEDELA AG]	Feeding Tube	2014-05-23
PMN K894206 | FMF MEDELA LLC [MEDELA AG]	Intopo Oral Syringe Adapter	2014-05-22
PMN K113678 | OMP MEDELA LLC [MEDELA AG]	Wound Dressing Set	2013-01-07
PMN K113678 | OMP MEDELA LLC [MEDELA AG]	MEDELA INVIA MOTION	2013-01-07
OHH MEDELA LLC [MEDELA AG]	Symphony Double Pumping Kit	2013-01-03
OHH MEDELA LLC [MEDELA AG]	Symphony & Lactina Double Pumping Kit	2013-01-03
OHH MEDELA LLC [MEDELA AG]	Lactina Double Pumping Kit	2013-01-03
PMN K844297 | HGY MEDELA LLC [MEDELA AG]	Supplemental Nursing System (SNS)	2012-12-12
PMN K844297 | HGY MEDELA LLC [MEDELA AG]	Starter SNS	2012-12-12
NTC MEDELA LLC [MEDELA AG]	Tender Care Hydrogel Pad	2011-12-09
PMN K053052 | HGX MEDELA LLC [MEDELA AG]	MEDELA SWING	2011-04-19
PMN K031614 | HGX MEDELA LLC [MEDELA AG]	Pump In Style Advanced	2011-04-19
PMN K031614 | HGX MEDELA LLC [MEDELA AG]	Advanced Personal Double Breastpump	2011-04-19
PMN K875300 | HGX MEDELA LLC [MEDELA AG]	MEDELA LACTINA SELECT	2007-11-27
PMN K823840 | HGY MEDELA LLC [MEDELA AG]	Portable Manual Pump	2007-11-27
PMN K061435 | OMP MEDELA LLC [MEDELA AG]	MEDELA VARIO 8/18	2007-11-27
PMN K033179 | BTA MEDELA LLC [MEDELA AG]	MEDELA CLARIO	2007-11-27
PMN K962612 | LBI MEDELA LLC [MEDELA AG]	PHOTOLAMP PHOTOTHERAPY UNIT	2006-09-21
PMN K962612 | LBI MEDELA LLC [MEDELA AG]	MEDELA PHOTOLAMP PHOTOTHERAPY UNIT	2006-09-21
PMN K962612 | LBI MEDELA LLC [MEDELA AG]	MEDELA BILIBED	2006-09-21
PMN K853176 | HFS MEDELA LLC [MEDELA AG]	MEDELA NIPPLE SHIELDS	2006-09-21
PMN K020518 | HGX MEDELA LLC [MEDELA AG]	POWERED (MUTIPLE BRANDS)	2006-09-21
PMN K020518 | HGX MEDELA LLC [MEDELA AG]	MEDELA SYMPHONY	2006-09-21
PMN K020518 | HGX MEDELA LLC [MEDELA AG]	MEDELA BREASTPUMPS	2006-09-21
HGY MEDELA LLC [MEDELA AG]	Harmony	2006-09-21
FNN MEDELA LLC [MEDELA AG]	MEDELA SPECIAL NEEDS FEEDER	2006-09-21
FNN MEDELA LLC [MEDELA AG]	MEDELA SOFTFEEDER	2006-09-21
FNN MEDELA LLC [MEDELA AG]	MEDELA MINI SPECIAL NEEDS FEEDER	2006-09-21
KDQ MEDELA LLC [MEDELA AG]	MEDELA THORAX DRAINAGE SYSTEMS	2003-11-19
KDQ MEDELA LLC [MEDELA AG]	MEDELA CENTRAL VACUUM REGULATORS	2003-11-19
PMN K061205 | BTA MEDELA LLC [MEDELA AG]	MEDELA VARIO 8/18/CI	2003-07-25
PMN K061205 | BTA MEDELA LLC [MEDELA AG]	MEDELA DOMINANT 35CI	2003-07-25
PMN K061205 | BTA MEDELA LLC [MEDELA AG]	MEDELA BASIC 30	2003-07-25
PMN K021368 | BTA MEDELA LLC [MEDELA AG]	MEDELA VARIO 8/18/CI	2003-07-25
PMN K021368 | BTA MEDELA LLC [MEDELA AG]	MEDELA DOMINANT 35CI	2003-07-25
PMN K021368 | BTA MEDELA LLC [MEDELA AG]	MEDELA BASIC 30	2003-07-25
FRW MEDELA LLC [MEDELA AG]	Babyweigh II scale	2002-04-02
FRW MEDELA LLC [MEDELA AG]	Baby Checker Scale	2002-04-02
HFS MEDELA LLC [MEDELA AG]	Nipple Shield	1998-07-22
HFS MEDELA LLC [MEDELA AG]	Contact Nipple Shield	1998-07-22
IME MEDELA LLC [MEDELA AG]	GEL PAD	1991-02-25
IME MEDELA LLC [MEDELA AG]	BRA COMPRESS	1991-02-25

Related Finance Registrations

NCAGE Code	8T389	MEDELA LLC
CAGE Code	8T389	MEDELA LLC
S.A.M. Registration	8T389 [52002029]	MEDELA LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092956332	57073 -> Long Beach, California	SOLENOID VALVE	288 CTN
2020092929458	Taichung,China (Taiwan) -> Long Beach, California	SUB-ASSEMBLY	175 CTN
2020092636001	Shanghai ,China (Mainland) -> Tacoma, Washington	DISPOSABLE NURSING PAD	5624 CTN
2020092633154	Shanghai ,China (Mainland) -> Tacoma, Washington	DISPOSABLE NURSING PAD	5823 CTN
2020092635997	Shanghai ,China (Mainland) -> Tacoma, Washington	DISPOSABLE NURSING PAD	1708 CTN
2020092529183	Rotterdam,Netherlands -> New York, New York	MEDICAL EQUIPMENT	23 PKG
2020092415630	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	12 PKG
2020092331501	Hong Kong,Hong Kong -> Long Beach, California	BATTERY HOLDER (PLASTIC BOX)	288 CTN