510k
Database
Specialties
Anesthesiology
507
Cardiovascular
1577
Chemistry
355
Dental
1263
Ear, Nose, Throat
233
Gastroenterology & Urology
911
General & Plastic Surgery
2096
General Hospital
1788
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
445
Neurology
918
Obstetrics & Gynecology
417
Ophthalmic
265
Orthopedic
2673
Pathology
49
Physical Medicine
502
Radiology
2281
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
360
LLZ
System, Image Processing,...
350
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
290
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
239
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Smiths Medical International , Ltd.
Medical Device Manufacturer
·
US , Waukesha , WI
Smiths Medical International , Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2005
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smiths Medical International , Ltd.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 16, 2013
PNEUPAC PARAPAC PLUS
K123957
·
BTL
Anesthesiology
·
269d
Cleared
Oct 04, 2007
PNEUPAC VR1 AIR MIX
K071527
·
BTL
Anesthesiology
·
122d
Cleared
Aug 05, 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322
·
BTL
Anesthesiology
·
77d
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3
Anesthesiology
3