510k
Database
Specialties
Anesthesiology
534
Cardiovascular
1644
Chemistry
359
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
956
General & Plastic Surgery
2174
General Hospital
2037
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
952
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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S & W Medico Teknik
Medical Device Manufacturer
·
US , Walker , MI
S & W Medico Teknik - FDA 510(k) Cleared Devices
46 submissions
·
46 cleared
·
Since 1984
46
Total
46
Cleared
0
Denied
FDA 510(k) Regulatory Record - S & W Medico Teknik
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 29, 1993
MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA
K915633
·
FLL
General Hospital
·
609d
Cleared
Sep 21, 1992
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000
·
FMZ
General Hospital
·
516d
Cleared
Nov 02, 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119
·
FLL
General Hospital
·
33d
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46
Cardiovascular
28
Anesthesiology
15
General Hospital
3