FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
160345–160368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 03, 1982
RHYTHM WHEEL
K813497 · LHD
Tropical Enterprises, Inc.
Obstetrics & Gynecology · 140d
Cleared May 03, 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264 · JTO
Vitek Systems, Inc.
Microbiology · 90d
Cleared May 03, 1982
BOGER AUTO-TRACTION DEVICE
K820663 · ILZ
D.C. Medical Device, Inc.
Radiology · 54d
Cleared May 03, 1982
DERMA PRENE
K820665 · KGO
Ansell, Inc.
General Hospital · 53d
Cleared May 03, 1982
BANDBAG, WRAP, STERILE
K820692 · MMP
Contour Fabricators, Inc.
General Hospital · 52d
Cleared May 03, 1982
LA VEL LATERAL VIEW EXTENSION LENS
K820732 · HOI
Peter M. Tolliver
Ophthalmic · 47d