Company ยท US
Landauer
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2019. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
40recalls (0 in 12 months)
39recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2024 | Landauer microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059 Completed |
LHO | None listed |
| Dec 22, 2023 | Landauer Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer NanoDots, Model Numbers:
a) BC30023, description: QC Set For Microstar Dots;
b) BC30083, description: nanoDot QC Set - 80kVp - Sale;
c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Constancy (Cs-137) nanoDot D2DNN, Model Numbers:
a) 18155-000 (EMEA number VKITCON001);
b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Constancy (80 kVp) nanoDot D2DNN, Model Numbers:
a) 18150-000 (EMEA number VKITCON002);
b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (unexposed) nanoDot D2DNS, Model Numbers:
a) 18140-000;
b) 18140-KIT;
c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18135-000;
b) 18135-KIT;
c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18131-000;
b) 18131-KIT;
c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18130-000;
b) 18130-KIT;
c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18125-000;
b) 18125-KIT;
c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18121-000;
b)18121-KIT;
c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18120-000;
b) 18120-KIT;
c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 18105-000;
b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 18100-000;
b) 18100-1MO;
c) 18100-2MO;
d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN , Model Numbers:
a) 04293-000;
b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04225-000 (EMEA number VINLNAN005);
b) 04225-KIT;
c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04224-000 (EMEA number VINLNAN006);
b) 04224-KIT;
c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04218-000 (EMEA number VINLNAN004);
b) 04218-KIT;
c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04217-000 (EMEA number VINLNAN003);
b) 04217-KIT;
c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DXS, Model Numbers:
a) 03063-1MO;
b) 03063-3MO;
c) 03063-OTO;
d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DXS, Model Numbers:
a) 03062-1MO;
b) 03062-3MO;
c) 03062-OTO;
d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DXN, Model Numbers:
a) 03061-1MO;
b) 03061-3MO;
c) 03061-OTO;
d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DXN, Model Numbers:
a) 03060-1MO;
b) 03060-3MO;
c) 03060-OTO;
d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03057-1MO;
b) 03057-3MO;
c) 03057-OTO;
d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03056-000 (EMEA number VINLNAN002);
b) 03056-1MO;
c) 03056-3MO;
d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03055-1MO;
b) 03055-3MO;
c) 03055-OTO;
d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 03053-1MO;
b) 03053-1WK ;
c) 03053-3MO;
d) 03053-OTO;
e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 03051-1MO;
b) 03051-3MO;
c) 03051-OTO;
d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |
| Sep 12, 2023 | Landauer nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | K192196 |