510k
Database
Specialties
Anesthesiology
464
Cardiovascular
1397
Chemistry
334
Dental
1094
Ear, Nose, Throat
200
Gastroenterology & Urology
827
General & Plastic Surgery
1837
General Hospital
1310
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
783
Obstetrics & Gynecology
350
Ophthalmic
221
Orthopedic
2447
Pathology
47
Physical Medicine
417
Radiology
2022
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
296
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
241
LZA
Polymer Patient Examination Glove
228
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
169
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Heraeus Kulzer, Inc.
Medical Device Manufacturer
·
US , Elkhart , IN
Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices
145 submissions
·
145 cleared
·
Since 1988
145
Total
145
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heraeus Kulzer, Inc.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 02, 1990
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430
·
FMK
General & Plastic Surgery
·
63d
Filters
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All
145
Dental
74
Chemistry
53
Hematology
8
Radiology
6
Toxicology
3
General & Plastic Surgery
1