510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
934
General & Plastic Surgery
2142
General Hospital
2009
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
458
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942
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429
Ophthalmic
272
Orthopedic
2757
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
406
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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Paneffort, LLC
Medical Device Manufacturer
·
US , Rochester, , NY
Paneffort, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paneffort, LLC
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 30, 2022
Paneffort AAMI Level 3 Isolation Gown
K212717
·
FYC
General Hospital
·
460d
Cleared
Jul 25, 2022
Paneffort 3-ply Surgical and Procedural Masks
K221409
·
FXX
General Hospital
·
70d
Filters
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2
General Hospital
2