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
150697–150720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1984
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
MAGNESIUM REAGENT SET
K843893 · JGJ
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
TOTAL CALCIUM REAGENT SET
K843895 · CIC
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 30, 1984
TDX REA CREATININE
K843916 · CGX
Abbott Laboratories
Chemistry · 25d
Cleared Oct 30, 1984
SPOTTEST LOEFFLER METHYLENE BLUE STAIN
K843919 · KFC
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Oct 30, 1984
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
K843930 · CGJ
Euro-Diagnostics BV
Immunology · 25d
Cleared Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
K843938 · KNK
Simmler, Inc.
Chemistry · 21d
Cleared Oct 30, 1984
PYR BROTH
K843987 · JTO
Remel Co.
Microbiology · 19d
Cleared Oct 30, 1984
FOCUS URIC ACID
K844011 · KNK
Abbott Laboratories
Chemistry · 18d
Cleared Oct 30, 1984
CREATININE REAGENT SET
K844024 · CGX
Livonia Diagnostics, Inc.
Chemistry · 15d
Cleared Oct 30, 1984
URIC ACID REAGENT SET
K844075 · LFQ
Livonia Diagnostics, Inc.
Chemistry · 11d
Cleared Oct 30, 1984
STRAIGHT AND BUBBLE OXYGEN TUBING
K844083 · CAT
Hudson Extrusions, Inc.
Anesthesiology · 11d
Cleared Oct 30, 1984
POLYVINYL CHLORIDE CANNULAS
K844084 · CAT
Hudson Extrusions, Inc.
Anesthesiology · 11d
Cleared Oct 29, 1984
SERVOMED PULSE AMPLIFIER MODULE-206-
K840523 · DRT
Litton Medical Electronics
Cardiovascular · 265d
Cleared Oct 29, 1984
CARDIORHYTHM 2000
K841472 · DSH
Biogenix, Inc.
Cardiovascular · 203d
Cleared Oct 26, 1984
ELECTRONIC BLOOD PRESS. METER EN-212
K832076 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 486d
Cleared Oct 26, 1984
PERSONAL DEFIBRILLATOR
K832833 · LDD
Physio-Control, Inc.
Cardiovascular · 434d
Cleared Oct 26, 1984
DIASCOPE 2
K833689 · DRT
S & W Medico Teknik
Cardiovascular · 374d
Cleared Oct 26, 1984
FITNESS LOGGER
K840020 · DPS
Britt Corp., Inc.
Cardiovascular · 295d
Cleared Oct 26, 1984
TELEPHONE RECEIVERS R101 R111
K840032 · DXH
Biometric Products, Inc.
Cardiovascular · 295d
Cleared Oct 26, 1984
FITEX
K840036
Britt Corp., Inc.
Physical Medicine · 295d
Cleared Oct 26, 1984
SURG-A STAT LOOP TIP
K840376 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 273d