510k
Database
Specialties
Anesthesiology
482
Cardiovascular
1460
Chemistry
338
Dental
1158
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1911
General Hospital
1453
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
823
Obstetrics & Gynecology
364
Ophthalmic
239
Orthopedic
2512
Pathology
49
Physical Medicine
443
Radiology
2079
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
311
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
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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Pennwalt Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Pennwalt Corp. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 1978
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pennwalt Corp.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 28, 1983
INTREX
K833241
·
EAP
Radiology
·
67d
Cleared
Mar 03, 1980
XR-710
K800063
·
EAP
Radiology
·
52d
Cleared
Mar 03, 1980
PANOREX II DENTAL X-RAY UNIT
K800133
·
EHD
Radiology
·
42d
Filters
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6
Radiology
3
Dental
2
Anesthesiology
1