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
132001–132024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1989
VIRGO(R) VZV-IGG ELISA
K883427 · GQX
Electro-Nucleonics, Inc.
Microbiology · 207d
Cleared Mar 10, 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · EWO
Welch Allyn, Inc.
Ear, Nose, Throat · 155d
Cleared Mar 10, 1989
EXTRA STRENGTH SKIN LESS SKIN CONDOM
K884402 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 142d
Cleared Mar 10, 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · CHH
Heraeus Kulzer, Inc.
Chemistry · 116d
Cleared Mar 10, 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · DRX
S & W Medico Teknik
Cardiovascular · 101d
Cleared Mar 10, 1989
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
K885092 · KPL
Medical Imaging Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 10, 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · LIT
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Mar 10, 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · DYB
Oscor Medical Corp.
Cardiovascular · 51d
Cleared Mar 10, 1989
CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
K890504 · JOD
Gish Biomedical, Inc.
Cardiovascular · 37d
Cleared Mar 10, 1989
GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES
K890538 · LYY
Boston Medical Corp.
General Hospital · 35d
Cleared Mar 10, 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · JQW
Hichem Diagnostics
Chemistry · 32d
Cleared Mar 10, 1989
TRACHEOSTOMY CARE AND CLEANING KITS
K890726 · LRO
Cypress Medical Products, Ltd.
General & Plastic Surgery · 25d
Cleared Mar 10, 1989
NON-STERILE, BULK GAUZE SPONGES
K890727 · EFQ
Cypress Medical Products, Ltd.
General & Plastic Surgery · 25d
Cleared Mar 10, 1989
DRY TIPS
K890734 · KHR
Microcopy, Div. Neo-Flo, Inc.
Dental · 25d
Cleared Mar 10, 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 23d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Mar 09, 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 302d
Cleared Mar 09, 1989
ARGIS PULMONARY FUNCTION TESTING SYSTEM
K883732 · BZC
Advanced Signal Processing, Inc.
Anesthesiology · 190d
Cleared Mar 09, 1989
NR2000 CARDIAC MONITOR
K883903 · DPS
Nirad , Ltd.
Cardiovascular · 175d
Cleared Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 136d
Cleared Mar 09, 1989
ELECTRODE GEL
K884504 · DPS
Herbert Stanley Co.
Cardiovascular · 135d
Cleared Mar 09, 1989
OPTIFIELD I AND II AUTOMATED PERIMETERS
K884867 · HPT
Optimed, Inc.
Ophthalmic · 108d
Cleared Mar 09, 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · DSF
Mennen Medical, Inc.
Cardiovascular · 106d