510k
Database
Specialties
Anesthesiology
493
Cardiovascular
1526
Chemistry
348
Dental
1202
Ear, Nose, Throat
222
Gastroenterology & Urology
884
General & Plastic Surgery
2004
General Hospital
1547
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
870
Obstetrics & Gynecology
386
Ophthalmic
254
Orthopedic
2608
Pathology
49
Physical Medicine
471
Radiology
2178
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
326
LLZ
System, Image Processing,...
322
LZA
Polymer Patient Examination Glove
297
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
264
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
187
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Mark One Healthcare Products
Medical Device Manufacturer
·
US , Mchenry , IL
Mark One Healthcare Products - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1977
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mark One Healthcare Products
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 29, 1989
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K891986
·
KME
General Hospital
·
276d
Cleared
Mar 23, 1977
DRAPES, MODESTY
K770396
·
KKX
General Hospital
·
22d
Cleared
Feb 16, 1977
SKIN PRESSURE PROTECTORS
K761268
·
FMP
General Hospital
·
62d
Filters
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5
General Hospital
3
General & Plastic Surgery
1
Orthopedic
1