510k
Database
Specialties
Anesthesiology
459
Cardiovascular
1392
Chemistry
334
Dental
1086
Ear, Nose, Throat
200
Gastroenterology & Urology
826
General & Plastic Surgery
1827
General Hospital
1292
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
779
Obstetrics & Gynecology
348
Ophthalmic
220
Orthopedic
2444
Pathology
47
Physical Medicine
417
Radiology
2017
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
294
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
243
HRS
Plate, Fixation, Bone
241
LZA
Polymer Patient Examination Glove
225
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
169
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R & D Batteries, Inc.
Medical Device Manufacturer
·
US , Burnsville , MN
R & D Batteries, Inc. - FDA 510(k) Cleared Devices
53 submissions
·
53 cleared
·
Since 1993
53
Total
53
Cleared
0
Denied
FDA 510(k) Regulatory Record - R & D Batteries, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034
·
HLJ
Ophthalmic
·
36d
Cleared
Feb 22, 1994
R&D BATTERIES # 5615, 5234, 5097
K935988
·
HLI
Ophthalmic
·
70d
Cleared
Feb 22, 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018
·
HLJ
Ophthalmic
·
68d
Cleared
Feb 22, 1994
R & D BATTERIES
K936104
·
HLJ
Ophthalmic
·
62d
Filters
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All
53
General Hospital
19
Gastroenterology & Urology
18
Ophthalmic
4
Obstetrics & Gynecology
2
Cardiovascular
2
Radiology
2
Physical Medicine
2
Ear, Nose, Throat
1
Hematology
1
Orthopedic
1