MAUDE Summary for May, 2026

Brent Cotter |

With the FDA's MAUDE data for May 2026 now available to the public, we spent some time to go over the numbers.  The largest percentage of entries are diabetic devices, which we've omitted. For all other entries containing a GTIN, we've listed the top 50 items based on number of entries. The raw data can be found HERE.

Total reported: 292,350 

Diabetes devices: 121,336 (41.5%)

All other devices: 171,014 (58.5%)

Top 50 by Volume:

Rank Count GTIN Brand Name Manufacturer
1 2,493 10885403533228 BD PYXIS MEDSTATION ES CAREFUSION 303, INC.
2 1,360 10885403810046 ALARIS SYSTEM CAREFUSION 303, INC.
3 940 00606959051515 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
4 818 00606959051522 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
5 771 00606959426887 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
6 763 10885403533235 BD PYXIS MEDSTATION ES AUXILIARY CAREFUSION 303, INC.
7 548 00606959424159 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
8 530 00643169633759 CAPSUREFIX NOVUS LEAD MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
9 439 00886874119808 ENDOWRIST INTUITIVE SURGICAL, INC
10 426 00606959424197 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
11 424 05415067017246 OCTRODE LEAD KIT, 60CM LENGTH ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
12 403 00855778005005 LIFEVEST WCD 4000 SYSTEM ZOLL MANUFACTURING CORPORATION
13 393 07332747161274 NOBELPARALLEL CC RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
14 368 10885403533242 BD PYXIS ANESTHESIA STATION ES CAREFUSION 303, INC.
15 329 07332747161205 NOBELPARALLEL CC NP 3.75X10MM NOBEL BIOCARE AB GÖTEBORG
16 322 07332747160062 NOBELACTIVE INTERNAL RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
17 317 00802526559266 ACCOLADE MRI EL DR BOSTON SCIENTIFIC CORPORATION
18 310 00813502012279 IMPELLA ABIOMED, INC.
19 296 00606959427006 DREAMSTATION AUTO CPAP RESPIRONICS, INC.
20 279 10885403512698 BD PYXIS MEDSTATION ES AUXILIARY TOWER CAREFUSION 303, INC.
21 269 00886874110720 DAVINCI XI INTUITIVE SURGICAL, INC
22 264 00886874119785 ENDOWRIST INTUITIVE SURGICAL, INC
23 262 07332747160512 NOBELREPLACE CC RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
24 255 07332747127423 NOBELACTIVE TIULTRA RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
25 247 10885403810015 ALARIS SYSTEM CAREFUSION 303, INC.
26 240 07332747161212 NOBELPARALLEL CC NP 3.75X11.5MM NOBEL BIOCARE AB GÖTEBORG
27 238 00643169633742 CAPSUREFIX NOVUS LEAD MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
28 235 07332747161267 NOBELPARALLEL CC RP 4.3X8.5MM NOBEL BIOCARE AB GÖTEBORG
29 232 07332747160024 NOBELACTIVE INTERNAL NP 3.5X10MM NOBEL BIOCARE AB GÖTEBORG
30 223 10885403519284 ALARIS SYSTEM CAREFUSION 303, INC.
31 222 00886874112298 ENDOWRIST INTUITIVE SURGICAL, INC
32 217 00606959426900 DREAMSTATION EXPERT RESPIRONICS, INC.
33 215 00643169356566 SPRINT QUATTRO SECURE S MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
34 205 07332747160031 NOBELACTIVE INTERNAL NP 3.5X11.5MM NOBEL BIOCARE AB GÖTEBORG
35 204 00802526559273 ACCOLADE MRI EL DR BOSTON SCIENTIFIC CORPORATION
36 199 00763000315467 INTELLIS MEDTRONIC PUERTO RICO OPERATIONS CO.
37 199 07332747127966 NOBELPARALLEL CC TIULTRA RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
38 198 00763000740269 SELECTSECURE MRI SURESCAN MEDTRONIC PUERTO RICO VILLALBA
39 195 00813502012828 IMPELLA ABIOMED, INC.
40 195 07332747160079 NOBELACTIVE INTERNAL RP 4.3X11.5MM NOBEL BIOCARE AB GÖTEBORG
41 194 00763000316846 AZURE XT DR MRI SURESCAN MEDTRONIC SINGAPORE OPERATIONS
42 191 00813024013297 THORATEC HEARTMATE 3 LVAS IMPLANT KIT THORATEC CORPORATION
43 191 07332747160710 NOBELREPLACE CC PMC RP 4.3X10MM NOBEL BIOCARE AB GÖTEBORG
44 187 30610586028339 CADD CLEO INFUSION SET ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
45 179 00802526559228 ACCOLADE MRI DR BOSTON SCIENTIFIC CORPORATION
46 177 05414734502887 TENDRIL STS ABBOTT MEDICAL (CRM-SYLMAR)
47 173 07332747127386 NOBELACTIVE TIULTRA NP 3.5X13MM NOBEL BIOCARE AB GÖTEBORG
48 173 07332747127379 NOBELACTIVE TIULTRA NP 3.5X11.5MM NOBEL BIOCARE AB GÖTEBORG
49 171 10885403516047 ALARIS SYSTEM CAREFUSION 303, INC.
50 170 00886874110898 DAVINCI XI INTUITIVE SURGICAL, INC