510k
Database
Specialties
Anesthesiology
475
Cardiovascular
1438
Chemistry
336
Dental
1131
Ear, Nose, Throat
210
Gastroenterology & Urology
840
General & Plastic Surgery
1891
General Hospital
1436
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
426
Neurology
811
Obstetrics & Gynecology
362
Ophthalmic
237
Orthopedic
2473
Pathology
49
Physical Medicine
439
Radiology
2060
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
277
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Pie Data Medical BV
Medical Device Manufacturer
·
NL , Maastricht 6227 Aj
Pie Data Medical BV - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1987
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pie Data Medical BV
Obstetrics & Gynecology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 02, 1988
PIE MEDICAL SCANNER 1000
K870058
·
KNG
Obstetrics & Gynecology
·
391d
Cleared
Feb 02, 1988
ULTRASOUND LINEAR/SECTOR SCANNER 1100
K870653
·
KNG
Obstetrics & Gynecology
·
350d
Cleared
Aug 04, 1987
FETAL CARE MONITOR ANTEPARTUM 1500
K871082
·
HGM
Obstetrics & Gynecology
·
139d
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5
Obstetrics & Gynecology
3
Radiology
1
Ear, Nose, Throat
1