510k
Database
Specialties
Anesthesiology
4586
Cardiovascular
11400
Chemistry
10034
Dental
7164
Ear, Nose, Throat
2253
Gastroenterology & Urology
5973
General & Plastic Surgery
9824
General Hospital
8120
Hematology
2242
Immunology
2840
Medical Genetics
18
Microbiology
5371
Neurology
3397
Obstetrics & Gynecology
2166
Ophthalmic
1755
Orthopedic
13711
Pathology
766
Physical Medicine
1886
Radiology
9316
Toxicology
2368
Categories
GEX
Powered Laser Surgical Instrument
1681
GEI
Electrosurgical, Cutting &...
1310
LLZ
System, Image Processing,...
1236
HRS
Plate, Fixation, Bone
1042
IYN
System, Imaging, Pulsed Doppler,...
922
ESD
Hearing Aid, Air-conduction,...
879
LNH
System, Nuclear Magnetic...
872
JWH
Prosthesis, Knee,...
838
GCJ
Laparoscope, General & Plastic...
837
DZE
Implant, Endosseous, Root-form
821
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
DE
Gke-GmbH
Medical Device Manufacturer
·
DE , Waldems
Gke-GmbH - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2017
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gke-GmbH
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 07, 2017
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
K163144
·
FRC
General Hospital
·
149d
Filters
Filter by Specialty
All
1
General Hospital
1