510k
Database
Specialties
Anesthesiology
487
Cardiovascular
1478
Chemistry
342
Dental
1165
Ear, Nose, Throat
216
Gastroenterology & Urology
856
General & Plastic Surgery
1936
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
839
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2550
Pathology
49
Physical Medicine
454
Radiology
2105
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
260
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
250
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Carapace, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Carapace, Inc. - FDA 510(k) Cleared Devices
22 submissions
·
10 cleared
·
Since 1979
22
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carapace, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 22, 1994
I.V. START KIT
K931729
·
FOZ
General Hospital
·
321d
Cleared
Feb 07, 1994
CARAPACE DEBRIDEMENT KITS
K931669
·
FRG
General Hospital
·
307d
Cleared
Dec 02, 1993
CARAPACE STERILE COTTON BALLS
K931626
·
FRL
General Hospital
·
244d
Cleared
Jul 03, 1979
SURGICAL FACE MASK
K790970
·
KKX
General Hospital
·
42d
Filters
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All
22
General & Plastic Surgery
9
General Hospital
4
Orthopedic
3
Physical Medicine
2
Obstetrics & Gynecology
2
Anesthesiology
1
Cardiovascular
1