Data / Medical devices / Austria / Leonhard Lang GMBH

Leonhard Lang GMBH: FDA-registered device maker in INNSBRUCK Tirol, Austria, 8 510(k) clearances

Name: Leonhard Lang GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Leonhard Lang GMBH is registered with the FDA (registration 8020045) in INNSBRUCK Tirol, Austria. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 21, 2009. 6 recall events name it as the recalling firm (3 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Leonhard Lang GMBH

FDA registration number: 8020045
FEI number: 6736
Address: Archenweg 56, INNSBRUCK Tirol, Austria, A-6020
Owner or operator: LEONHARD LANG GMBH (8020045)
Roles: Contract manufacturer, Manufacturer
First device listed: January 30, 2007
Registered through: 2027
Brand names listed: S&W ECG Electrodes, S&W ESU Dispersive Electrodes, S&W Healthcare, Skintact, Skintact ECG Electrodes, Skintact ECG Electrodes and accessories, Skintact ESU Dispersive Electrodes, others

Devices it lists

Device	Product code	Class	Role	Source
Automated External Defibrillators (Non-Wearable)	MKJ	3	Contract manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Contract manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph, Multi-Function	MLN	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Contract manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Contract manufacturer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Contract manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2009	K092291	SKINTACT AND VARIOUS OTHER TRADENAMES	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
February 1, 2008	K080106	SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
November 16, 2007	K073104	SKINTACT AND VARIOUS OTHER TRADENAMES	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
November 21, 2006	K063161	SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL	GEI	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
February 24, 2004	K040249	SKINTACT ECG ELECTRODE	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
January 16, 2003	K024264	SKINTACT	DRX	Substantially Equivalent	Leonhard Lang Co.	accessdata.fda.gov
January 16, 2003	K024247	SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov
November 14, 2002	K023503	SKINTACT ECG ELECTRODE	DRX	Substantially Equivalent	Leonhard Lang GmbH	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2017	77949	Class I	Terminated	Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for singl	Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.	accessdata.fda.gov
September 1, 2016	75181	Class I	Terminated	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.	There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.	accessdata.fda.gov
November 2, 2015	72575	Class II	Terminated	ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionet	There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.	accessdata.fda.gov
February 24, 2015	70704	Class II	Terminated	Skintact ECG Electrode FS-50, Catalog no. 58028, & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram	The electrodes may fail to transmit signals.	accessdata.fda.gov
December 3, 2014	69930	Class I	Terminated	GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005.. Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, les	The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.	accessdata.fda.gov
July 10, 2009	52794	Not yet classified	Terminated	SKINTACT Electrodes for Defibrillation, 10X REF DF20, Rx only, Manufactured by Leonhard Lang GmbH, Archenweg 56, 6020 Innsbruck, Austria. The device is non-sterile and single use. For use on adults and children over eigh	A potential risk was identified associated with the connectors of the defibrillation electrodes DF20. It was found that some of the connectors do not slip easily into the sockets of the defibrillator or an extension cord of the defibrillator. In such cases increased force or some wiggling is required to insert the connector fully. A potential risk for patien	accessdata.fda.gov

Compare with other makers

Updated September 12, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.