510k
Database
Specialties
Anesthesiology
494
Cardiovascular
1528
Chemistry
348
Dental
1205
Ear, Nose, Throat
223
Gastroenterology & Urology
885
General & Plastic Surgery
2011
General Hospital
1555
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
437
Neurology
871
Obstetrics & Gynecology
387
Ophthalmic
254
Orthopedic
2612
Pathology
49
Physical Medicine
473
Radiology
2183
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
327
LLZ
System, Image Processing,...
323
LZA
Polymer Patient Examination Glove
301
GEI
Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
265
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
202
MAX
Intervertebral Fusion Device...
189
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Hexcel Medical
Medical Device Manufacturer
·
US , Mchenry , IL
Hexcel Medical - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1976
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hexcel Medical
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 23, 1984
HEXCELITE
K840416
·
ITG
Physical Medicine
·
52d
Cleared
Jun 23, 1982
URETHANE ORTHOPAEDIC CASTING TAPE
K820890
·
ITG
Physical Medicine
·
85d
Cleared
May 27, 1981
URETHANE ORTHOPAEDIC CASTING TAPE
K811164
·
ITG
Physical Medicine
·
29d
Cleared
Nov 01, 1976
HEXCELITE SHEET SPLINTS
K760841
·
ITG
Physical Medicine
·
19d
Filters
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All
13
Orthopedic
8
Physical Medicine
4
Microbiology
1