510k
Database
Specialties
Anesthesiology
339
Cardiovascular
1083
Chemistry
276
Dental
831
Ear, Nose, Throat
149
Gastroenterology & Urology
643
General & Plastic Surgery
1345
General Hospital
782
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
370
Neurology
592
Obstetrics & Gynecology
250
Ophthalmic
160
Orthopedic
2074
Pathology
40
Physical Medicine
315
Radiology
1613
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
232
IYN
System, Imaging, Pulsed Doppler,...
212
HRS
Plate, Fixation, Bone
211
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
200
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
171
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
139
MAX
Intervertebral Fusion Device...
138
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Pudenz-Schulte Medical Research Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Pudenz-Schulte Medical Research Corp. - FDA 510(k) Cleared Devices
40 submissions
·
39 cleared
·
Since 1980
40
Total
39
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 08, 1982
P-S SUCTION RESERVIOR
K820474
·
GCY
General & Plastic Surgery
·
17d
Cleared
Jan 05, 1982
PS-ROUND SURG. DRAIN & CONNECTOR
K813377
·
GCY
General & Plastic Surgery
·
35d
Cleared
Jul 14, 1980
P-S SURGICAL DRAIN
K801442
·
GCY
General & Plastic Surgery
·
24d
Cleared
Jul 14, 1980
P-S SUCTION RESERVOIR
K801443
·
GCY
General & Plastic Surgery
·
24d
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40
Neurology
24
General Hospital
10
General & Plastic Surgery
4
Gastroenterology & Urology
1
Cardiovascular
1