510k
Database
Specialties
Anesthesiology
331
Cardiovascular
1056
Chemistry
268
Dental
798
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1314
General Hospital
747
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
568
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2042
Pathology
38
Physical Medicine
309
Radiology
1577
Toxicology
131
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
209
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
198
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
154
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Opus Medical, Inc.
Medical Device Manufacturer
·
US , Albuquerque, , NM
Opus Medical, Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 2001
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Opus Medical, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 19, 2004
OPUS SPEEDSTITCH SUTURE DEVICE
K042031
·
GAT
General & Plastic Surgery
·
83d
Cleared
Apr 23, 2003
F1 DIODE LASER SYSTEM
K030235
·
GEX
General & Plastic Surgery
·
90d
Cleared
Mar 27, 2001
F1 DIODE LASER SYSTEM
K004021
·
GEX
General & Plastic Surgery
·
90d
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13
Orthopedic
6
Gastroenterology & Urology
4
General & Plastic Surgery
3