Leonhard Lang GmbH
INNSBRUCK Tirol, AT
LEONHARD LANG GMBH appears in FDA device records in INNSBRUCK Tirol, AT. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Leonhard Lang GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Leonhard Lang Medizintechnik GmbHenforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Leonhard Lang GmbH between 1999 and 2014. The busiest year on record is 2003, with 5. The most recent is 2014, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2014 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142803 | Skintact, various other tradenames | MKJ | Substantially Equivalent | |
| K140500 | SKINTACT | GEI | Substantially Equivalent | |
| K140340 | SKINTACT | GXY | Substantially Equivalent | |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | MKJ | Substantially Equivalent | |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | Substantially Equivalent | |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | MKJ | Substantially Equivalent | |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | DRX | Substantially Equivalent | |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | DRX | Substantially Equivalent | |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS | MKJ | Substantially Equivalent | |
| K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | GEI | Substantially Equivalent | |
| K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 | MKJ | Substantially Equivalent | |
| K040249 | SKINTACT ECG ELECTRODE | DRX | Substantially Equivalent | |
| K030362 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES | GEI | Substantially Equivalent | |
| K030509 | SKINTACT ECG TAB ELECTRODE | DRX | Substantially Equivalent | |
| K024264 | SKINTACT | DRX | Substantially Equivalent | |
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | DRX | Substantially Equivalent | |
| K023920 | SKINTACT | DRX | Substantially Equivalent | |
| K023503 | SKINTACT ECG ELECTRODE | DRX | Substantially Equivalent | |
| K982521 | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES | DRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8020045 | 6736 | LEONHARD LANG GMBH | ARCHENWEG 56, INNSBRUCK Tirol A-6020 AT | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MKJAutomated External Defibrillators (Non-Wearable)
- KMKDevice, Intravascular Catheter Securement
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- MLNElectrode, Electrocardiograph, Multi-Function
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWQFull-Montage Standard Electroencephalograph
- BZQMonitor, Breathing Frequency
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- DQAOximeter
- MSXSystem, Network And Communication, Physiological Monitors
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3109-2017 | 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 single use only. Used with automated external defibrillators | 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. | Class I | Terminated | |
| Z-0004-2017 | 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. | Class I | Terminated | |
| Z-0292-2016 | 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 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG | 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. | Class II | Terminated | |
| Z-1350-2015 | 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 (ECG) or vectorcardiogram. | The electrodes may fail to transmit signals. | Class II | Terminated | |
| Z-0802-2015 | 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, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only. | 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. | Class I | Terminated | |
| Z-2234-2009 | S&W Electrodes for Defibrillation, 10 Defibrillation Electrodes, Reorder #90101, S & W Healthcare Corp, 1525 Flight Path Drive Brooksville, Florida 34604 The device is non-sterile and single use. For use on adults and children over eight years old for external defibrillation, pacing, monitoring, and cardioversion. | 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 patients exist, if (a) such a connector (b) | Terminated | ||
| Z-2233-2009 | 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 eight years old for external defibrillation, pacing, monitoring, and cardioversion. | 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 patients exist, if (a) such a connector (b) | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain