510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2729
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
264
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Ballard Medical Products
Medical Device Manufacturer
·
US , Mchenry , IL
Ballard Medical Products - FDA 510(k) Cleared Devices
26 submissions
·
24 cleared
·
Since 1982
26
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ballard Medical Products
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 11, 1998
72 HOUR USE TRACH CARE WITH MICROBAN
K974630
·
CAH
General Hospital
·
89d
Cleared
May 08, 1992
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
K915109
·
FPA
General Hospital
·
177d
Cleared
Jan 15, 1988
SAFETY SHIELD KIT
K873731
·
FXX
General Hospital
·
158d
Filters
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All
26
Anesthesiology
12
General & Plastic Surgery
5
Gastroenterology & Urology
4
General Hospital
3
Ear, Nose, Throat
2