510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
369
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
978
General & Plastic Surgery
2198
General Hospital
2048
Hematology
126
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99
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8
Microbiology
470
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965
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436
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279
Orthopedic
2944
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52
Physical Medicine
515
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2448
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Acro Biomedical Co., Ltd.
Medical Device Manufacturer
·
TW , Kaohsiung City
Acro Biomedical Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Acro Biomedical Co., Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 18, 2024
ABCcolla® Collagen ADM Scaffold
K233378
·
KGN
General & Plastic Surgery
·
382d
Cleared
May 10, 2017
ABCcolla Collagen Matrix
K162348
·
KGN
General & Plastic Surgery
·
261d
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4
Orthopedic
2
General & Plastic Surgery
2