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
IYN
System, Imaging, Pulsed Doppler,...
247
HRS
Plate, Fixation, Bone
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
Immunology
✕
5
devices
1-5 of 5
Filters
Cleared
Mar 09, 1983
ROENTGENOGRAPHY SET
K830229
·
DGD
Immunology
·
44d
Cleared
Jul 22, 1982
RIA-QUANT FPA TEST KIT
K821151
·
DAN
Immunology
·
87d
Cleared
Apr 06, 1977
RIA-DAC TM HTSH KIH
K770604
·
JLW
Immunology
·
6d
Cleared
Feb 07, 1977
SPAC TM T3 UPTAKE KIT
K770033
·
KHQ
Immunology
·
28d
Cleared
Feb 07, 1977
SPAC TM T4 RIA KIT
K770156
·
CDX
Immunology
·
14d
Filters
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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