510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1612
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
928
General & Plastic Surgery
2135
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2704
Pathology
52
Physical Medicine
515
Radiology
2334
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
370
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
266
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Mallinckrodt Manufacturing, LLC
Medical Device Manufacturer
·
US , Madison , WI
Mallinckrodt Manufacturing, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mallinckrodt Manufacturing, LLC
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 03, 2025
EVOLVE Nitric Oxide Delivery System
K242578
·
MRN
Anesthesiology
·
127d
Cleared
Dec 06, 2023
Evolve Nitric Oxide Delivery System
K222930
·
MRN
Anesthesiology
·
436d
Cleared
Apr 20, 2023
Inomax DSIR
K211153
·
MRN
Anesthesiology
·
731d
Cleared
Jun 17, 2020
INOmax DSIR Plus
K200389
·
MRN
Anesthesiology
·
120d
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Anesthesiology
4