510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Welldoc, Inc.
Medical Device Manufacturer
·
US , Baltimore , MD
Welldoc, Inc. - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 2010
11
Total
11
Cleared
0
Denied
FDA 510(k) cleared devices by Welldoc, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888
·
QRX
Chemistry
·
322d
Cleared
Jul 28, 2023
BlueStar and BlueStar Rx
K230813
·
NDC
Chemistry
·
126d
Cleared
Sep 08, 2021
BlueStar Rx
K203434
·
NDC
Chemistry
·
289d
Cleared
Apr 07, 2020
BlueStar Rx
K193654
·
MRZ
Chemistry
·
99d
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11
General Hospital
7
Chemistry
4