510k
Database
Specialties
Anesthesiology
683
Cardiovascular
2084
Chemistry
458
Dental
1690
Ear, Nose, Throat
303
Gastroenterology & Urology
1186
General & Plastic Surgery
2604
General Hospital
2364
Hematology
142
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128
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12
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569
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1186
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533
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355
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3719
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57
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569
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2953
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168
Categories
LLZ
System, Image Processing,...
488
LZA
Polymer Patient Examination Glove
444
GEX
Powered Laser Surgical Instrument
427
FXX
Mask, Surgical
386
GEI
Electrosurgical, Cutting &...
381
IYN
System, Imaging, Pulsed Doppler,...
358
HRS
Plate, Fixation, Bone
345
MAX
Intervertebral Fusion Device...
297
QIH
Automated Radiological Image...
285
OLO
Orthopedic Stereotaxic Instrument
282
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Manufacturers
US
Molnlycke Health Care Us, LLC
Medical Device Manufacturer
·
US , Norcross , GA
Molnlycke Health Care Us, LLC - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2006
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
Filters
1
2
Cleared
Sep 10, 2007
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
K071565
·
KGO
General Hospital
·
95d
Cleared
Dec 20, 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847
·
KGO
General Hospital
·
77d
1
2
Filters
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27
General Hospital
16
General & Plastic Surgery
9
Cardiovascular
2