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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118705–118728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1991
ASPIRATING ENDO OCULAR PROBE
K914247 · EQH
Surgical Technologies, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 18, 1991
EDWARDS ANATO HOOK/UNIV ROD/WASH/SACR SCREW/ADJ CO
K914269 · KWP
Scientific Spinal , Ltd.
Orthopedic · 85d
Cleared Dec 18, 1991
READS(R) IGA ANTI-CARDIOLIPIN TEST KIT
K914405 · MID
Reads Medical Products, Inc.
Immunology · 77d
Cleared Dec 18, 1991
DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE
K914422 · DQY
Devices For Vascular Intervention, Inc.
Cardiovascular · 76d
Cleared Dec 18, 1991
OHIO CARE PLUS INCUBATOR
K914487 · FMZ
Ohmeda Medical
General Hospital · 71d
Cleared Dec 18, 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · MEA
C.R. Bard, Inc.
General Hospital · 70d
Cleared Dec 18, 1991
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
K914507 · LAT
Diagnostic Products Corp.
Toxicology · 70d
Cleared Dec 18, 1991
ICAN GT DRAINAGE BAG
K914530 · FRQ
Icn Pharmaceuticals, Inc.
Gastroenterology & Urology · 68d
Cleared Dec 18, 1991
RICH-MAR IFV 1000
K914539 · IPF
Rich-Mar Corp.
Physical Medicine · 68d
Cleared Dec 18, 1991
CORDIS BIPAL BIOPSY FORCEPS
K914567 · DWZ
Cordis Corp.
Cardiovascular · 64d
Cleared Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · CFR
Heraeus Kulzer, Inc.
Chemistry · 56d
Cleared Dec 18, 1991
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · DQX
Cordis Corp.
Cardiovascular · 50d
Cleared Dec 18, 1991
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · GZJ
Labeltape Meditect, Inc.
Neurology · 50d
Cleared Dec 18, 1991
VIRAPURE, CHLAMYPURE AND MYCOPURE
K914894 · JSM
Microtest
Microbiology · 48d
Cleared Dec 18, 1991
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
K915077 · CGX
Beckman Instruments, Inc.
Chemistry · 40d
Cleared Dec 18, 1991
RAI-TROL ELEVATED LIPIDS CONTROL
K915191 · JJY
Reagents Applications, Inc.
Chemistry · 29d
Cleared Dec 18, 1991
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · CGJ
Medix Biotech, Inc.
Chemistry · 30d
Cleared Dec 18, 1991
COCAINE METABOLITE EIA TEST
K915371 · DIO
Diagnostic Reagents, Inc.
Toxicology · 21d
Cleared Dec 17, 1991
LAPAROLITH
K905552 · LQC
Baxter Healthcare Corp
Gastroenterology & Urology · 371d
Cleared Dec 17, 1991
INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST
K911113 · ITX
Interson Corp.
Radiology · 285d
Cleared Dec 17, 1991
INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM
K911115 · ITX
Interson Corp.
Radiology · 285d
Cleared Dec 17, 1991
INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST
K911117 · ITX
Interson Corp.
Radiology · 285d
Cleared Dec 17, 1991
INTELECT, MODEL 245
K911733 · IMG
Chattanooga Group, Inc.
Physical Medicine · 244d
Cleared Dec 17, 1991
STAIRMASTER MODEL 6000 ERGOMETER
K912140 · ISD
Tri-Tech, Inc.
Physical Medicine · 217d