510(k) K012937 ยท HAW Neurological Stereotaxic Instrument
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
| Applicant | Medtronic Surgical Navigation Technologies, Louisville CO, US |
| Decision | Substantially Equivalent, Jan 25, 2002 |
| Received | Aug 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2014 | Medtronic Navigation, Inc. BAG 9732315 MOUSE STERILE 15 PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. BIOPSY NEEDLE KIT, 9733068, PASSIVE Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. BIT 9733516 2.9mm DRILL STERILE Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. DISP 9730950 STRL SPHERE, 1 PK INSERT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. DISP 9730951 STRL SPHERE, 5PK INSERT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. DRAPE 9732722 TUBE STERILE O-ARM 20PK Terminated |
GXY | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. ENT PRGM 9734636 ADD FUSION NAV AxiEM Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. INST 9731132 KIT CR REF FRAME DRIVER 5PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. INSTRUMENT TRACKER 9733533XOM ENT 1PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. KIT, 9731427, THORACIC TACTILE PROBES Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. MOUSE 9732721 STERILE O-ARM 10PK Terminated |
GXY | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. PACK 9731975 TUMOR RESECTION AXIEM CR Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. PATIENT TRACKER 9733534XOM ENT 1PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. PIN, 9733235, 100MM, STERILE, PERC REF Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. PIN, 9733236, 150MM, STERILE, PERC REF Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. SHUNT KIT 9733605 NON-INVASIVE Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. SPHERES 8801071 1/TRAY 12PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. SPHERES 8801075 5/TRAY 12PK Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. TRAJ GUIDE KIT, 9733066, BIOPSY, INT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. TUMOR RES. PACK 9733553 AxiEM S.M. Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. TUMOR RESECTION KIT 9733607 NON-INVASIVE Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. TUMOR RESECTION KIT 9733608 SKULL MOUNT Terminated |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Terminated |
HAW | None listed |
| Dec 17, 2003 | Medtronic Surgical Navigation Tech, Inc Fix pins associated with Stealth Station Treatment Guidance Platform Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.