510k
Database
Specialties
Anesthesiology
446
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1360
Chemistry
333
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1052
Ear, Nose, Throat
194
Gastroenterology & Urology
806
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1772
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1201
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120
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84
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7
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419
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763
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334
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210
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2418
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44
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406
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1967
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143
Categories
GEX
Powered Laser Surgical Instrument
289
LLZ
System, Image Processing,...
281
GEI
Electrosurgical, Cutting &...
251
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Automated Radiological Image...
250
IYN
System, Imaging, Pulsed Doppler,...
240
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
202
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
167
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Bayer Corp., Agfa Div.
Medical Device Manufacturer
·
US , Ridgefield Park , NJ
Bayer Corp., Agfa Div. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Corp., Agfa Div.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 30, 1998
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY...
K981280
·
IXW
Radiology
·
22d
Cleared
Mar 09, 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597
·
KPR
Radiology
·
90d
Cleared
Jan 27, 1997
LR 5200 LASER FILM RECORDER
K964414
·
LMC
Radiology
·
83d
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3
Radiology
3