510k
Database
Specialties
Anesthesiology
525
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1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
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933
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2142
General Hospital
1999
Hematology
126
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91
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8
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449
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942
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429
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272
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2753
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52
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515
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2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Thi Total Healthcare Innovation GmbH
Medical Device Manufacturer
·
AT , Feistritz Im Rosental
Thi Total Healthcare Innovation GmbH - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thi Total Healthcare Innovation GmbH
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
May 30, 2025
ViVi® Toga Premium
K243522
·
FYA
General Hospital
·
197d
Cleared
Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214
·
FXY
General Hospital
·
449d
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2
General Hospital
2