510k
Database
Specialties
Anesthesiology
518
Cardiovascular
1598
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
926
General & Plastic Surgery
2126
General Hospital
1944
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
936
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2690
Pathology
52
Physical Medicine
510
Radiology
2315
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
399
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
328
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Dynarex Corp.
Medical Device Manufacturer
·
US , Brewster , NY
Dynarex Corp. - FDA 510(k) Cleared Devices
19 submissions
·
18 cleared
·
Since 1986
19
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dynarex Corp.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 22, 2005
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K052743
·
CBP
Anesthesiology
·
83d
Cleared
Jan 11, 1993
DYNAREX SUCTION CATHETERS & KITS
K922843
·
BSY
Anesthesiology
·
213d
Cleared
May 11, 1989
ORAL AIRWAY
K891586
·
CAE
Anesthesiology
·
52d
Cleared
Mar 04, 1986
TRACHEOSTOMY CARE KIT
K855130
·
BTO
Anesthesiology
·
71d
Filters
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19
General & Plastic Surgery
9
Anesthesiology
4
General Hospital
4
Obstetrics & Gynecology
2