510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1630
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
945
General & Plastic Surgery
2151
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
946
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2764
Pathology
52
Physical Medicine
515
Radiology
2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Harwill Medical (Pty) , Ltd.
Medical Device Manufacturer
·
US , Crofton , MD
Harwill Medical (Pty) , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1998
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 15, 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202
·
HHT
Obstetrics & Gynecology
·
182d
Cleared
Feb 26, 1999
HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
K983204
·
HFW
Obstetrics & Gynecology
·
165d
Filters
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4
Obstetrics & Gynecology
2
Anesthesiology
2