510k
Database
Specialties
Anesthesiology
454
Cardiovascular
1378
Chemistry
334
Dental
1076
Ear, Nose, Throat
198
Gastroenterology & Urology
818
General & Plastic Surgery
1815
General Hospital
1250
Hematology
123
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
770
Obstetrics & Gynecology
341
Ophthalmic
216
Orthopedic
2433
Pathology
46
Physical Medicine
416
Radiology
1996
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
296
LLZ
System, Image Processing,...
287
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
213
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
188
MAX
Intervertebral Fusion Device...
168
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Mallinckrodt Medical
Medical Device Manufacturer
·
US , St Louis , MO
Mallinckrodt Medical - FDA 510(k) Cleared Devices
43 submissions
·
42 cleared
·
Since 1990
43
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mallinckrodt Medical
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 06, 1995
UTK-DTE AUTILARY SHIELD
K954146
·
KPY
Radiology
·
92d
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43
Anesthesiology
22
Cardiovascular
13
General Hospital
5
Gastroenterology & Urology
2
Radiology
1