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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Drager, Inc.
Medical Device Manufacturer
·
US , Pittsburgh , PA
Drager, Inc. - FDA 510(k) Cleared Devices
20 submissions
·
15 cleared
·
Since 1991
20
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Drager, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198
·
FMT
General Hospital
·
186d
Cleared
Apr 25, 1997
DRAGER INCUBATOR 8000 IC
K954204
·
FMZ
General Hospital
·
597d
Cleared
Feb 09, 1996
DRAGER INFANT RADIANT WARMERN RH600
K953489
·
FMT
General Hospital
·
199d
Cleared
Dec 01, 1995
DRAGER PT4000 PHOTOTHERAPY SYSTEM
K954611
·
LBI
General Hospital
·
58d
Filters
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20
Anesthesiology
15
General Hospital
4
Physical Medicine
1