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
163657–163680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1981
FECAL STAINING KIT
K810875 · KKJ
Jayco Pharmaceuticals
Pathology · 31d
Cleared May 01, 1981
NDM DIATEMP INFANT ELECTROSURG. DISP. P.
K810920 · HAM
Ndm Corp.
General & Plastic Surgery · 25d
Cleared May 01, 1981
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
K810982 · JZO
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTISMOOTH MUSCLE ANTIBODY TEST SYS
K810983 · DBE
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
K810984 · DBM
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
K810985 · DHN
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
IBM 5885 DIGITAL ECG ACQUISITION CART
K810988 · DPS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
IBM 5880 ACQUISITION & ANALYSIS CART TEL
K810989 · LOS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
MICROERMA SYSTEM
K811001 · JQW
Dynatech Corp.
Toxicology · 18d
Cleared May 01, 1981
CC-100
K811016 · DPS
Anthro-Metrics Corp.
Cardiovascular · 16d
Cleared May 01, 1981
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
K811034 · LAR
Syva Co.
Toxicology · 15d
Cleared May 01, 1981
TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80
K811052 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 01, 1981
POLYETHYLENE MEDULLARY PLUG
K811060
Arthur A. Checchi, Inc.
General & Plastic Surgery · 14d
Cleared May 01, 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared May 01, 1981
VENES II
K811085 · DWL
Jung Products, Inc.
General Hospital · 10d
Cleared May 01, 1981
SUTURE REMOVAL SET(DISPLSABLE)
K811086 · KDD
Cunningham Woodland, Inc.
General & Plastic Surgery · 10d
Cleared May 01, 1981
MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL
K811087 · FSM
Cunningham Woodland, Inc.
General & Plastic Surgery · 10d
Cleared May 01, 1981
GELMAN ELECTROPHORESIS CONTROL
K811100 · JJY
Gelman Sciences, Inc.
Chemistry · 9d
Cleared Apr 29, 1981
MK6 ERA SYSTEM
K810473 · GWJ
Amplaid USA, Inc.
Neurology · 65d
Cleared Apr 29, 1981
SOMATOSENSORY STIMULATOR
K810482 · GWF
Amplaid USA, Inc.
Neurology · 65d
Cleared Apr 29, 1981
PLASTICEPH
K810538 · EAG
Morningstar Dental Co.
Radiology · 62d
Cleared Apr 29, 1981
AUDIOMETER
K810583 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 57d
Cleared Apr 29, 1981
HEMOPHRON
K810612 · FKQ
Renal Devices, Inc.
Gastroenterology & Urology · 54d
Cleared Apr 29, 1981
NEOCARE TEMPERATURE MONITOR
K810792 · FMZ
Vickers America Medical Corp.
General Hospital · 37d