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
162961–162984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1981
IMV MANIFOLDS
K811908 · CBO
Airlife, Inc.
Anesthesiology · 15d
Cleared Jul 16, 1981
CARDIOPULMUNARY RESUSCITATOR
K811909 · DRM
Michigan Instruments, Inc.
Cardiovascular · 15d
Cleared Jul 16, 1981
VISITEC NEEDLE RANGE (ANESTHESIOLOGY)
K811963 · BSP
Visitec Co.
Anesthesiology · 6d
Cleared Jul 15, 1981
WATER PISTOL
K811594 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 37d
Cleared Jul 15, 1981
SR-ISOCETTE
K811665 · ELK
J. Aderer, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE COLTEX/COLTOFLAX
K811666 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
COLTENE PRESSURE SPOT INDICATOR
K811667 · ELW
Coltene, Inc.
Dental · 30d
Cleared Jul 15, 1981
DRUG STANDARDS
K811674 · DKB
Supelco, Inc.
Chemistry · 30d
Cleared Jul 15, 1981
ENTRI ENTERNAL FEEDING SET
K811683 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 15, 1981
GENTAMICIN REAGENT TEST KIT
K811692 · LCD
Beckman Instruments, Inc.
Toxicology · 30d
Cleared Jul 15, 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710 · LCP
Bio-Rad
Toxicology · 28d
Cleared Jul 15, 1981
PARA-PAK
K811722 · HYI
Meridian Diagnostics, Inc.
Toxicology · 27d
Cleared Jul 15, 1981
PORTABLE AUDIOMETERS
K811727 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 27d
Cleared Jul 15, 1981
FINETONE MODEL VI HEARING AID
K811751 · ESD
Vicon Instrument Co.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
THERAPEUTIC DRUG CONTROL
K811756 · DIF
Icl Scientific
Toxicology · 23d
Cleared Jul 15, 1981
COLTENE PRESIDENT IMPRESSION MATERIALS
K811767 · ELW
Coltene, Inc.
Dental · 23d
Cleared Jul 15, 1981
AUDITORY LOCALIZER
K811772 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 23d
Cleared Jul 15, 1981
OCTOTOXIC SCREENER
K811790 · ETS
Western Advanced Technology, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 15, 1981
QUICK-CHEM COLORIMETER
K811806 · JJQ
The Dow Chemical Co.
Chemistry · 20d
Cleared Jul 15, 1981
URIC ACID TEST
K811810 · KNK
Environmental Chemical Specialties
Chemistry · 20d
Cleared Jul 15, 1981
UROPAPER EIKEN AG
K811817 · JIL
Syn-Kit, Inc.
Microbiology · 19d
Cleared Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
K811832 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jul 15, 1981
BILIRUBINOMETER
K811840 · JJQ
Advanced Instruments, Inc.
Chemistry · 14d
Cleared Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
K811849 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 14d