510k
Database
Specialties
Anesthesiology
353
Cardiovascular
1120
Chemistry
281
Dental
842
Ear, Nose, Throat
152
Gastroenterology & Urology
658
General & Plastic Surgery
1389
General Hospital
819
Hematology
103
Immunology
76
Medical Genetics
1
Microbiology
373
Neurology
608
Obstetrics & Gynecology
256
Ophthalmic
163
Orthopedic
2113
Pathology
40
Physical Medicine
332
Radiology
1647
Toxicology
133
Categories
GEX
Powered Laser Surgical Instrument
238
QIH
Automated Radiological Image...
216
IYN
System, Imaging, Pulsed Doppler,...
215
HRS
Plate, Fixation, Bone
212
LLZ
System, Image Processing,...
204
GEI
Electrosurgical, Cutting &...
192
OLO
Orthopedic Stereotaxic Instrument
177
NHA
Abutment, Implant, Dental,...
163
NKB
Thoracolumbosacral Pedicle Screw...
144
MAX
Intervertebral Fusion Device...
140
Browse all 339 categories →
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Smith & Nephew, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530 submissions
·
517 cleared
·
Since 1980
Official Website
530
Total
517
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smith & Nephew, Inc.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 15, 1992
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
K923285
·
ECB
Dental
·
71d
Cleared
Sep 30, 1991
MAX-I-PROBE IRRIGATION SYSTEM
K913030
·
EFS
Dental
·
83d
Cleared
Nov 04, 1987
HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
K864294
·
EGM
Dental
·
369d
Cleared
Nov 18, 1986
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
K864307
·
EIC
Dental
·
15d
Filters
Filter by Specialty
All
530
Orthopedic
376
General & Plastic Surgery
85
Neurology
14
General Hospital
14
Obstetrics & Gynecology
12
Ear, Nose, Throat
5
Radiology
5
Gastroenterology & Urology
5
Physical Medicine
5
Dental
4