510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Pentavest Holdings Sdn Bhd
Medical Device Manufacturer
·
MY , Batu
Pentavest Holdings Sdn Bhd - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pentavest Holdings Sdn Bhd
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 06, 2022
Penta Glove
K212847
·
LZA
General Hospital
·
121d
Cleared
Dec 27, 2021
Sterile Latex Surgical Gloves Powder Free
K212848
·
KGO
General Hospital
·
111d
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2
General Hospital
2