Leonhard Lang G M B H

FDA Filings

This page includes the latest FDA filings for Leonhard Lang G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8020045
• FEI Number: 6736
• Name: ELAINE DUNCAN, MS.ME., RAC, AIMBE
• Owner & Operator: LEONHARD LANG GMBH
• Contact Address: ARCHENWEG 56 --; INNSBRUCK AT-NOTA A-6020 AT
• Official Correspondent:
  • BURRHUS - LANG
  • 43-512-334257-x
• US Agent:
  • ELAINE DUNCAN, MS.ME., RAC, AIMBE
  • PALADIN MEDICAL, INC.
  • 715 5496035
  • 715 5495380
  • DUNCAN@PALADINMEDICAL.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 415 VALLEY VIEW TRAIL ; HOULTON, WI 54082 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 29005531000432 Leonhard Lang GmbH	SKINTACT PD50-F4C	2024-04-25
GUDID 29005531002573 Leonhard Lang GmbH	GE Healthcare ELT-F35S-1500	2023-09-22
GUDID 29005531002566 Leonhard Lang GmbH	GE Healthcare ELT-F50W-1200	2023-09-22
GUDID 29005531002559 Leonhard Lang GmbH	GE Healthcare ELT-PWIEC-NEO-150	2023-09-22
GUDID 29005531002542 Leonhard Lang GmbH	GE Healthcare ELT-RTABA-500	2023-09-22
GUDID 29005531002535 Leonhard Lang GmbH	GE Healthcare ELT-RTABPI-500	2023-09-22
GUDID 09005531002265 Leonhard Lang GmbH	Midmark 2-100-0207	2021-09-24
GUDID 29005531002191 Leonhard Lang GmbH	Dealmed 782015	2021-04-15
GUDID 29005531507771 Leonhard Lang GmbH	Megadyne 50777	2020-03-26
GUDID 39005531504609 Leonhard Lang GmbH	GE Healthcare 2059145-001	2018-07-06
GUDID 29005531589883 Leonhard Lang GmbH	Skintact T-604B	2018-07-06
GUDID 39005531595522 Leonhard Lang GmbH	Skintact FS-TB -7	2018-03-29
GUDID 39005531595171 Leonhard Lang GmbH	Skintact FS-VF01 -10	2018-03-29
GUDID 39005531593672 Leonhard Lang GmbH	Schiller 2.155031L	2018-03-29
GUDID 39005531593337 Leonhard Lang GmbH	Skintact RS25	2018-03-29
GUDID 39005531592989 Leonhard Lang GmbH	Skintact RO21	2018-03-29
GUDID 39005531592033 Leonhard Lang GmbH	Skintact FS-RC /4 -4	2018-03-29
GUDID 39005531592026 Leonhard Lang GmbH	Skintact FS-TB1 /5 -5	2018-03-29
GUDID 39005531591999 Leonhard Lang GmbH	Skintact FS-TB /3 -3	2018-03-29
GUDID 39005531591548 Leonhard Lang GmbH	Skintact RO21A30	2018-03-29
GUDID 39005531590848 Leonhard Lang GmbH	Skintact FS-VB011 -1200	2018-03-29
GUDID 39005531588630 Leonhard Lang GmbH	Skintact RT14	2018-03-29
GUDID 39005531587633 Leonhard Lang GmbH	Skintact FS-TB1	2018-03-29
GUDID 39005531586599 Leonhard Lang GmbH	Skintact RT41	2018-03-29
GUDID 39005531586568 Leonhard Lang GmbH	Skintact RT24	2018-03-29
GUDID 39005531584533 Leonhard Lang GmbH	Skintact FS-TB	2018-03-29
GUDID 39005531580269 Leonhard Lang GmbH	Skintact FS-40	2018-03-29
GUDID 39005531580023 Leonhard Lang GmbH	Skintact CT-50	2018-03-29
GUDID 39005531506498 Leonhard Lang GmbH	Skintact DF82I	2018-03-29
GUDID 39005531506443 Leonhard Lang GmbH	Skintact DF59NC	2018-03-29
GUDID 39005531506436 Leonhard Lang GmbH	Skintact DF59N	2018-03-29
GUDID 39005531506382 Leonhard Lang GmbH	Skintact DF27N	2018-03-29
GUDID 39005531506061 Leonhard Lang GmbH	Skintact DF27NC	2018-03-29
GUDID 39005531505484 Leonhard Lang GmbH	Skintact T-VO01	2018-03-29
GUDID 39005531503749 Leonhard Lang GmbH	Skintact FS-WA00 /10	2018-03-29
GUDID 39005531502919 Leonhard Lang GmbH	Skintact DF20NC	2018-03-29
GUDID 39005531502452 Leonhard Lang GmbH	Skintact DF28NC	2018-03-29
GUDID 39005531501165 Leonhard Lang GmbH	Skintact DF28N	2018-03-29
GUDID 39005531501134 Leonhard Lang GmbH	Skintact DF20N	2018-03-29
GUDID 39005531501066 Leonhard Lang GmbH	Scintilla SI-50	2018-03-29
GUDID 39005531500281 Leonhard Lang GmbH	Skintact DF29N	2018-03-29
GUDID 39005531500250 Leonhard Lang GmbH	Skintact	2018-03-29
GUDID 39005531000576 Leonhard Lang GmbH	Skintact FS-WA10C /5	2018-03-29
GUDID 29005531593248 Leonhard Lang GmbH	Skintact RS25A30	2018-03-29
GUDID 29005531591527 Leonhard Lang GmbH	Skintact RO21 /5	2018-03-29
GUDID 29005531586431 Leonhard Lang GmbH	Skintact FS-VB01	2018-03-29
GUDID 29005531580521 Leonhard Lang GmbH	Skintact W-601	2018-03-29
GUDID 29005531580514 Leonhard Lang GmbH	Skintact W-60	2018-03-29
GUDID 29005531580477 Leonhard Lang GmbH	Skintact T-601	2018-03-29
GUDID 29005531580460 Leonhard Lang GmbH	Skintact T-60	2018-03-29
GUDID 29005531580316 Leonhard Lang GmbH	Skintact FS-521	2018-03-29
GUDID 29005531580293 Leonhard Lang GmbH	Skintact FS-50C	2018-03-29
GUDID 29005531580286 Leonhard Lang GmbH	Skintact FS-50	2018-03-29
GUDID 29005531580088 Leonhard Lang GmbH	Skintact F-301	2018-03-29
GUDID 29005531580033 Leonhard Lang GmbH	Skintact CT-601	2018-03-29
GUDID 29005531505838 Leonhard Lang GmbH	Skintact FS-TC1 /10	2018-03-29
GUDID 29005531505753 Leonhard Lang GmbH	Skintact FS-RG1 /10	2018-03-29
GUDID 29005531000395 Leonhard Lang GmbH	Skintact W-130C /3	2018-03-29
GUDID 29005531000104 Leonhard Lang GmbH	Skintact EASICLIP	2018-03-29
GUDID 29005531000012 Leonhard Lang GmbH	Skintact FS-50C	2018-03-29
GUDID 19005531000084 Leonhard Lang GmbH	Skintact EASIPREP	2018-03-29
PMN K142803 | MKJ ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact Multifunction Electrodes	2015-03-17
PMN K142803 Leonhard Lang GmbH	Skintact, Various Other Tradenames	2014-12-02
PMN K140500 LEONHARD LANG GMBH	SKINTACT	2014-07-29
PMN K140340 LEONHARD LANG GMBH	SKINTACT	2014-05-21
PMN K103186 LEONHARD LANG GMBH	SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES	2011-02-08
PMN K092291 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact	2009-10-16
PMN K092291 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes and accessories	2009-10-16
PMN K092291 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W Healthcare	2009-10-16
PMN K080106 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact	2009-10-16
PMN K080106 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W Healthcare	2009-10-16
PMN K092291 LEONHARD LANG GMBH	SKINTACT AND VARIOUS OTHER TRADENAMES	2009-08-21
PMN K081371 LEONHARD LANG GMBH	SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL	2008-09-24
PMN K080106 LEONHARD LANG GMBH	SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE	2008-02-01
PMN K073104 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-12-07
PMN K073104 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes	2007-12-07
PMN K073104 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ECG Electrodes	2007-12-07
PMN K072233 | MKJ ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-12-07
PMN K072233 | MKJ ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact Multifunction Electrodes	2007-12-07
PMN K072233 | MKJ ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W Multifunction Electrodes	2007-12-07
PMN K040249 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-12-07
PMN K040249 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes	2007-12-07
PMN K040249 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ECG Electrodes	2007-12-07
PMN K030362 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-12-07
PMN K030362 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ESU Dispersive Electrodes	2007-12-07
PMN K030362 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ESU Dispersive Electrodes	2007-12-07
PMN K024264 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-12-07
PMN K024264 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes	2007-12-07
PMN K024264 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ECG Electrodes	2007-12-07
PMN K024247 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes	2007-12-07
PMN K024247 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ECG Electrodes	2007-12-07
PMN K023503 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ECG Electrodes	2007-12-05
PMN K023503 | DRX ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ECG Electrodes	2007-12-05
PMN K073104 LEONHARD LANG GMBH	SKINTACT AND VARIOUS OTHER TRADENAMES	2007-11-16
PMN K072233 LEONHARD LANG GMBH	SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS	2007-10-05
PMN K063161 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	others	2007-01-30
PMN K063161 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	Skintact ESU Dispersive Electrodes	2007-01-30
PMN K063161 | GEI ELAINE DUNCAN, MS.ME., RAC, AIMBE [LEONHARD LANG GMBH]	S&W ESU Dispersive Electrodes	2007-01-30
PMN K063161 LEONHARD LANG GMBH	SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL	2006-11-21
PMN K041883 LEONHARD LANG GMBH	SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21	2004-09-07
PMN K040249 LEONHARD LANG GMBH	SKINTACT ECG ELECTRODE	2004-02-24
PMN K030362 LEONHARD LANG GMBH	SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES	2003-04-14
PMN K030509 LEONHARD LANG GMBH	SKINTACT ECG TAB ELECTRODE	2003-03-04
PMN K024247 LEONHARD LANG GMBH	SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL	2003-01-16
PMN K023920 LEONHARD LANG GMBH	SKINTACT	2003-01-16
PMN K023503 LEONHARD LANG GMBH	SKINTACT ECG ELECTRODE	2002-11-14

Related Finance Registrations

NCAGE Code	0222N	LEONHARD LANG GMBH
NCAGE Code	0494N	LEONHARD LANG GMBH
CAGE Code	0222N	LEONHARD LANG GMBH
CAGE Code	0494N	LEONHARD LANG GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090419856	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRODES HS: 9018 19	1 PCS
2020090220468	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRODES HS: 9018 19	1 PCS
202008278121	Stadersand,Federal Republic of Germany -> Los Angeles, California	HS CODE:901819	3 PKG
2020082214972	Stadersand,Federal Republic of Germany -> Los Angeles, California	HS CODE:901819	3 PKG
2020082026041	Stadersand,Federal Republic of Germany -> Los Angeles, California	HS CODE:901819	3 PKG
202007246985	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRODES HS: 9018 19	8 PCS
2020071812610	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRODES HS: 9018 19	8 PCS
2020071516614	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRODES HS: 9018 19	8 PCS