Data / Medical devices / Netherlands / Physio-Control Maastricht, Inc.
Physio-Control Maastricht, Inc.: FDA-registered device maker in Maastricht Limburg, Netherlands, 5 510(k) clearances and 3 PMA approvals
Physio-Control Maastricht, Inc. is registered with the FDA (registration 3010030355) in Maastricht Limburg, Netherlands. It lists 2 device types. The FDA files 5 510(k) clearances and 3 PMA approvals under its listings, the newest dated December 21, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010030355
- Address
- Gaetano Martinolaan 50, Maastricht Limburg, Netherlands, 6229 GS
- Owner or operator
- Stryker Corp. (10058200)
- Roles
- Complaint file establishment
- First device listed
- July 26, 2018
- Registered through
- 2027
- Brand names listed
- LIFEPAK 1000, LIFEPAK 12, LIFEPAK 15, LIFEPAK 20, LIFEPAK 20E, LIFEPAK 35, LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery, LIFEPAK 500 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Complaint file establishment | accessdata.fda.gov |
| Compressor, Cardiac, External | DRM | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| February 8, 2018 | K173553 | LUCAS 3 Chest Compression System | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
| November 9, 2016 | K161768 | LUCAS 3 Chest Compression System | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
| December 22, 2010 | K102972 | LIFEPAK 12 | MKJ | Substantially Equivalent | Physio-Control, Inc. | accessdata.fda.gov |
| June 17, 2009 | K090422 | LUCAS 2 | DRM | Substantially Equivalent | Jolife AB | accessdata.fda.gov |
| February 17, 2006 | K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | Medtronic Emergency Response Systems, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 21, 2018 | P170018 | LIFEPAK® CR2 Defibrillator | MKJ | 25 | July 30, 2026 | accessdata.fda.gov |
| July 2, 2018 | P160026 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE | MKJ | 71 | September 24, 2026 | accessdata.fda.gov |
| December 21, 2017 | P160012 | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger | MKJ | 6 | April 18, 2023 | accessdata.fda.gov |
Compare with other makers
- All makers of Compressor, Cardiac, External
- All makers of Automated External Defibrillators (Non-Wearable)
Updated July 30, 2026. 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.