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
161185–161208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1982
T4 DIAGNOSTIC KIT
K820251 · CDP
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared May 05, 1982
TBG DIAGNOSTIC KIT
K820252 · CEE
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared May 05, 1982
BIOSTRIP G
K820594 · JIL
Helena Laboratories
Chemistry · 62d
Cleared May 05, 1982
OPTACRY/95 BLUE CONTACT LENS BLANKS
K820815 · HPX
Optacryl, Inc.
Ophthalmic · 42d
Cleared May 05, 1982
OPTACRY/ 95 GREEN CONTACT LENS BLANKS
K820816 · HPX
Optacryl, Inc.
Ophthalmic · 42d
Cleared May 05, 1982
OPTACRY/95 GRAY CONTACT LENS BLANKS
K820817 · HPX
Optacryl, Inc.
Ophthalmic · 42d
Cleared May 05, 1982
VAN-TEC FASCIAL DILATOR
K820865 · GCC
Van-Tec, Inc.
General & Plastic Surgery · 37d
Cleared May 05, 1982
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869 · GDX
Van-Tec, Inc.
General & Plastic Surgery · 37d
Cleared May 05, 1982
ASPIRATOR/IRRIGATOR OR I/A UNIT
K820889 · KYG
Mid Laboratories, Inc.
Ophthalmic · 36d
Cleared May 05, 1982
BOSWORTH WOODEN WEDGES
K820892
Harry J. Bosworth Co.
Dental · 36d
Cleared May 05, 1982
VENTRE/SPEC IGE CONTROLS
K820897 · DGC
Ventrex Laboratories, Inc.
Immunology · 36d
Cleared May 05, 1982
THC-CANNABINOIDS DIRECT URINE RIA KIT
K820903 · LAT
Immunalysis Corporation
Toxicology · 35d
Cleared May 05, 1982
DENTISCOPE
K820907 · EAY
Chayes Virginia, Inc.
Dental · 34d
Cleared May 05, 1982
DENTAL ARCH BAR
K820944 · DYX
Unisplint Corp.
Dental · 29d
Cleared May 05, 1982
BOND-ON
K820955 · EJS
J. Aderer, Inc.
Dental · 29d
Cleared May 05, 1982
AUDIO-ADI, AA SERIES
K820993 · ESD
Audio-Aid, Inc.
Ear, Nose, Throat · 27d
Cleared May 05, 1982
MODEL IM9
K821042 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 05, 1982
DSL 1020
K821068 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 19d
Cleared May 05, 1982
SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
K821097
Icl Scientific
Immunology · 15d
Cleared May 05, 1982
TOTAL RADIOIMMUNOASSAY KIT
K821101 · CDX
Bioclinical Group
Chemistry · 15d
Cleared May 05, 1982
MEGNESIUM REAGENT KIT
K821102 · JGJ
Anco Medical Reagents & Assoc.
Chemistry · 15d
Cleared May 05, 1982
CHOLESTEZYME-V EIKEN
K821105 · CHH
Syn-Kit, Inc.
Chemistry · 15d
Cleared May 05, 1982
TRIGLYZYME V EIKEN
K821106 · JGY
Syn-Kit, Inc.
Chemistry · 15d
Cleared May 05, 1982
ETHOX FOOD PUMP STAND W/POLE CLAMP
K821148 · FRN
Ethox Corp.
General Hospital · 12d