510k
Database
Specialties
Anesthesiology
545
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1703
Chemistry
377
Dental
1351
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250
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981
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2215
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2065
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126
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100
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8
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474
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980
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439
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282
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2995
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52
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515
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2474
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155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
303
HRS
Plate, Fixation, Bone
287
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Westmark, Sterile Packing Systems, Inc. (Sps)
Medical Device Manufacturer
·
US , Grand Rapids , MI
Westmark, Sterile Packing Systems, Inc. (Sps) - FDA 510(k) Cleared De...
28 submissions
·
26 cleared
·
Since 1988
28
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Westmark, Sterile Packing Systems, Inc. (Sps)
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 23, 1990
PARACERVICAL/PUDENDAL TRAYS
K896799
·
CAZ
Anesthesiology
·
143d
Cleared
Feb 22, 1990
TRACHEOSTOMY TRAY
K896798
·
BTO
Anesthesiology
·
83d
Cleared
Feb 16, 1990
SUCTION CATHETER KIT
K896797
·
BSY
Anesthesiology
·
77d
Cleared
Jan 22, 1990
MUCOUS TRAP
K896560
·
BSY
Anesthesiology
·
66d
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28
General Hospital
10
Gastroenterology & Urology
7
General & Plastic Surgery
5
Anesthesiology
4
Chemistry
1
Microbiology
1