Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
160465–160488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869 · JFJ
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870 · CJE
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM PHOS
K821874 · CEO
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875 · CDT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876 · CIT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
REF. ELECTRODE SOL'N.
K821885 · JIX
Avl Scientific Corp.
Chemistry · 18d
Cleared Jul 13, 1982
PHILLIPS RADIATION MEASURING INSTRUMENT
K821892 · JJJ
Long Island Scientific
Chemistry · 15d
Cleared Jul 13, 1982
CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP
K821906 · KNT
Corpak Medsystems
Gastroenterology & Urology · 15d
Cleared Jul 13, 1982
TABLE, OPERATING, FIELD 6530-00-709-8175
K821923 · FWX
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 14d
Cleared Jul 13, 1982
TABLE, OPERATING, FIELD 6530-00-709-8155
K821924 · FSE
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 14d
Cleared Jul 13, 1982
UROCOMP MODEL 1404
K821939 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d
Cleared Jul 13, 1982
MODEL LS 3000 LINEAR SCANNER
K827377
Hitachi Medical Corp.
Radiology · 84d
Cleared Jul 09, 1982
MEADOX WOVEN DOUBLE VELOUR
K820696 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 119d
Cleared Jul 09, 1982
ELECTRICAL VIBRATING DEVICE
K821133 · IRO
Durham Electric Co.
Physical Medicine · 80d
Cleared Jul 09, 1982
MULTILUMEN INTRAVENOUS INFUSION CATHETER
K821220 · GBP
Clincal Instruments Corp.
General & Plastic Surgery · 73d
Cleared Jul 09, 1982
STERILE SUTURE REMOVAL KIT
K821502 · KDD
Pro-Pak
General & Plastic Surgery · 51d
Cleared Jul 09, 1982
LEBANON MICROSCOPE
K821689 · EPT
The Lebanon Corp.
General & Plastic Surgery · 31d
Cleared Jul 09, 1982
NAGASHIMA F60MM ATTACH. LENS
K821705 · FXQ
Kelleher Corp.
General & Plastic Surgery · 30d
Cleared Jul 09, 1982
ARGYLE GERZOF ABCESS DRAINAGE CATHETER
K821732
Sherwood Medical Co.
Cardiovascular · 25d
Cleared Jul 09, 1982
AMSCO ENDOSCOPY TABLE
K821749 · GDC
American Sterilizer Co.
General & Plastic Surgery · 24d
Cleared Jul 09, 1982
HEMO-NATE L-P KIT
K821814 · KDD
Int'L Corp.
General & Plastic Surgery · 21d
Cleared Jul 09, 1982
MODEL IC 3000
K827292
Xonics Medical Systems, Inc.
Radiology · 32d
Cleared Jul 09, 1982
CILCO ASCAN
K827371
Cilco, Inc.
Radiology · 102d
Cleared Jul 09, 1982
SCANNER TYPE 1846
K827380
Bruel & Kjaer Instruments, Inc.
Radiology · 80d