MAUDE Summary for June 2026

MAUDE Summary for June 2026

Brent Cotter |

The FDA's MAUDE data for June 2026 is now available to the public. We spent some time to go over the numbers, and here is what we found. Please note, the largest percentage of entries are diabetic devices, which we've omitted. 

Total reported: 328,057 

Diabetes devices: 138,417 (42.2%)

All other devices: 189,640 (57.8%)

Top 50 by Volume:

Rank Count GTIN Brand Name Manufacturer
1 3,012 10885403533228 BD PYXIS MEDSTATION ES CAREFUSION 303, INC.
2 2,043 00606959051515 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
3 1,463 10885403810046 ALARIS SYSTEM CAREFUSION 303, INC.
4 1,138 00606959426887 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
5 1,023 00606959424159 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
6 987 00606959051522 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
7 924 10885403533235 BD PYXIS MEDSTATION ES AUXILIARY CAREFUSION 303, INC.
8 669 00606959424197 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
9 530 00643169633759 CAPSUREFIX NOVUS LEAD MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
10 520 00763000441005 MIDAS REX MR8 MDT POWERED SURGICAL SOLUTIONS
11 516 00813502010022 IMPELLA ABIOMED, INC.
12 492 10885403533242 BD PYXIS ANESTHESIA STATION ES CAREFUSION 303, INC.
13 459 00855778005005 LIFEVEST WCD 4000 SYSTEM ZOLL MANUFACTURING CORPORATION
14 423 05415067017246 OCTRODE LEAD KIT, 60CM LENGTH ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
15 422 00606959427006 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
16 370 07332747161274 NOBELPARALLEL CC RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
17 368 00886874119808 ENDOWRIST INTUITIVE SURGICAL, INC
18 322 00606959025639 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
19 321 00813502011401 IMPELLA ABIOMED, INC.
20 310 00606959426900 DREAMSTATION EXPERT RESPIRONICS, INC.
21 308 10885403512698 BD PYXIS MEDSTATION ES AUXILIARY TOWER CAREFUSION 303, INC.
22 308 00813502012279 IMPELLA ABIOMED, INC.
23 307 00802526559266 ACCOLADE MRI EL DR BOSTON SCIENTIFIC CORPORATION
24 300 00606959025646 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
25 300 07332747160062 NOBELACTIVE INTERNAL RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
26 292 30610586028339 CADD CLEO INFUSION SET ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
27 292 07332747161205 NOBELPARALLEL CC NP 3.75X10MM NOBEL BIOCARE AB GÖTEBORG
28 290 00606959426849 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
29 287 00886874110720 DAVINCI XI INTUITIVE SURGICAL, INC
30 278 00813024013297 THORATEC HEARTMATE 3 LVAS IMPLANT KIT THORATEC CORPORATION
31 251 07332747127423 NOBELACTIVE TIULTRA RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
32 248 00886874119785 ENDOWRIST INTUITIVE SURGICAL, INC
33 241 00606959424173 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
34 238 10885403519284 ALARIS SYSTEM CAREFUSION 303, INC.
35 230 00886874110898 DAVINCI XI INTUITIVE SURGICAL, INC
36 226 00724995198503 HEXAVUE BLACK DIAMOND VIDEO, INC.
37 224 10885403810015 ALARIS SYSTEM CAREFUSION 303, INC.
38 224 07332747160024 NOBELACTIVE INTERNAL NP 3.5X10MM NOBEL BIOCARE AB GÖTEBORG
39 222 00802526559273 ACCOLADE MRI EL DR BOSTON SCIENTIFIC CORPORATION
40 218 10885403516047 ALARIS SYSTEM CAREFUSION 303, INC.
41 214 00643169633742 CAPSUREFIX NOVUS LEAD MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
42 211 00813502012828 IMPELLA ABIOMED, INC.
43 210 00840682102346 CARESCAPE DATEX-OHMEDA, INC.
44 208 00886874112298 ENDOWRIST INTUITIVE SURGICAL, INC
45 206 00886874120767 ENDOWRIST INTUITIVE SURGICAL, INC
46 204 00802526559228 ACCOLADE MRI DR BOSTON SCIENTIFIC CORPORATION
47 197 07332747161212 NOBELPARALLEL CC NP 3.75X11.5MM NOBEL BIOCARE AB GÖTEBORG
48 196 07332747161267 NOBELPARALLEL CC RP 4.3X8.5MM NOBEL BIOCARE AB GÖTEBORG
49 193 07332747127966 NOBELPARALLEL CC TIULTRA RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
50 188 00643169356566 SPRINT QUATTRO SECURE S MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA