510k
Database
Specialties
Anesthesiology
513
Cardiovascular
1593
Chemistry
356
Dental
1286
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2115
General Hospital
1899
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
933
Obstetrics & Gynecology
422
Ophthalmic
267
Orthopedic
2684
Pathology
52
Physical Medicine
507
Radiology
2300
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
392
LLZ
System, Image Processing,...
360
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
295
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
Browse all 339 categories →
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Flexicare Medical Limited.
Medical Device Manufacturer
·
GB , Mountain Ash
Flexicare Medical Limited. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2016
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Flexicare Medical Limited.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
K191909
·
CAH
General Hospital
·
250d
Cleared
Mar 22, 2017
ThermoShield HME Filter
K163300
·
CAH
General Hospital
·
120d
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Anesthesiology
6
General Hospital
2