510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1456
Chemistry
338
Dental
1153
Ear, Nose, Throat
214
Gastroenterology & Urology
845
General & Plastic Surgery
1906
General Hospital
1448
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
427
Neurology
821
Obstetrics & Gynecology
363
Ophthalmic
239
Orthopedic
2504
Pathology
49
Physical Medicine
439
Radiology
2073
Toxicology
146
Categories
GEX
Powered Laser Surgical Instrument
310
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
280
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Mallinckrodt Critical Care
Medical Device Manufacturer
·
US , Mchenry , IL
Mallinckrodt Critical Care - FDA 510(k) Cleared Devices
92 submissions
·
92 cleared
·
Since 1976
Official Website
92
Total
92
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mallinckrodt Critical Care
Toxicology
✕
1
devices
1-1 of 1
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Cleared
Nov 01, 1976
SPAC DIGOXIN KIT
K760800
·
DON
Toxicology
·
24d
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All
92
Chemistry
34
Anesthesiology
16
Cardiovascular
15
General Hospital
9
Immunology
5
Gastroenterology & Urology
5
Hematology
4
Radiology
2
Toxicology
1
General & Plastic Surgery
1