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Anesthesiology
1833
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6525
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5470
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3650
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703
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3212
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5318
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4424
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1203
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1531
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15
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3122
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2139
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1135
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809
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9391
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377
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1117
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6185
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1531
Categories
GEI
Electrosurgical, Cutting &...
870
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System, Image Processing,...
841
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Plate, Fixation, Bone
719
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System, Imaging, Pulsed Doppler,...
652
GEX
Powered Laser Surgical Instrument
647
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System, Nuclear Magnetic...
628
JWH
Prosthesis, Knee,...
572
NKB
Thoracolumbosacral Pedicle Screw...
512
MAX
Intervertebral Fusion Device...
503
LZA
Polymer Patient Examination Glove
497
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510k Database
Manufacturers
GB
Penlon Limited
Medical Device Manufacturer
·
GB , Oxon
Penlon Limited - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2005
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Penlon Limited
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
May 10, 2006
SIGMA ALPHA VAPORIZER
K060331
·
CAD
Anesthesiology
·
90d
Cleared
Mar 03, 2006
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K053564
·
CAD
Anesthesiology
·
71d
Cleared
Sep 23, 2005
AV-S ANAESTHESIA VENTILATOR
K051222
·
CBK
Anesthesiology
·
134d
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3
Anesthesiology
3