510k
Database
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Anesthesiology
508
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1577
Chemistry
355
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1264
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233
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915
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2098
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1798
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126
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91
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8
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445
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919
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418
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265
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2673
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49
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502
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2281
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154
Categories
LZA
Polymer Patient Examination Glove
363
LLZ
System, Image Processing,...
350
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Powered Laser Surgical Instrument
347
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Electrosurgical, Cutting &...
290
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Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
245
OLO
Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Pharmacaribe
Medical Device Manufacturer
·
US , Bonita Springs , FL
Pharmacaribe - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2009
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pharmacaribe
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 13, 2013
PULMOSAL
K130091
·
CAF
Anesthesiology
·
57d
Cleared
Sep 01, 2010
NESSI OTC SPACER
K101532
·
NVO
Anesthesiology
·
90d
Cleared
Aug 17, 2010
PHARMACARIBE INHALED SALINE SOLUTIONS
K101424
·
CAF
Anesthesiology
·
89d
Cleared
Nov 20, 2009
NESSI SPACER
K091862
·
NVO
Anesthesiology
·
150d
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4
Anesthesiology
4