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
117409–117432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1992
VIVAMED FISTULA NEEDLE
K903440 · FIE
S.S. Ent.
Gastroenterology & Urology · 629d
Cleared Apr 20, 1992
TUTOPLAST DURA
K910555 · LEM
Pfrimmer-Viggo GmbH & Co.
Neurology · 438d
Cleared Apr 20, 1992
ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE
K912742 · FLL
Spacelabs, Inc.
General Hospital · 304d
Cleared Apr 20, 1992
THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES
K914309 · HDD
Hill-Rom, Inc.
Obstetrics & Gynecology · 208d
Cleared Apr 20, 1992
TARGET THERAPEUTICS COILS
K914786 · KRD
Target Therapeutics
Cardiovascular · 180d
Cleared Apr 20, 1992
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
K915775 · DXO
Millar Instruments, Inc.
Cardiovascular · 118d
Cleared Apr 20, 1992
IDENTI LOOPS DEGANIA SILICONE
K920104 · DSS
Puritas Health Care, Inc.
Cardiovascular · 102d
Cleared Apr 20, 1992
OSTEONICS MICROSURFACED CDH HIP STEM
K920250 · JDI
Stryker Corp.
Orthopedic · 90d
Cleared Apr 20, 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 87d
Cleared Apr 20, 1992
ULTIMATE
K920444 · DWL
Jobst Institute, Inc.
General Hospital · 77d
Cleared Apr 20, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920720 · JAA
Shimadzu Medical Systems
Radiology · 62d
Cleared Apr 20, 1992
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
K921528 · IQA
Hill-Rom, Inc.
Physical Medicine · 18d
Cleared Apr 17, 1992
SECTOR TRANSDUCER MODEL NO. AWP3.5/A
K910966 · ITX
Kretztechnik AG
Radiology · 408d
Cleared Apr 17, 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498 · DQO
Cordis Corp.
Cardiovascular · 130d
Cleared Apr 17, 1992
TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
K920314 · DIS
Syntex Corp.
Toxicology · 85d
Cleared Apr 17, 1992
T4 EIA BEAD ASSAY
K920766 · CDX
Tech-Co, Inc.
Chemistry · 58d
Cleared Apr 17, 1992
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
K920809 · JIS
King Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 17, 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 49d
Cleared Apr 17, 1992
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K920940 · JJY
Eastman Kodak Company
Chemistry · 50d
Cleared Apr 17, 1992
MULTIPLE ACCESSORY TO GAMMA CAMERAS
K920962 · IYZ
Nu Age Products
Radiology · 74d
Cleared Apr 17, 1992
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Apr 17, 1992
CANNABINOID URINE CONTROLS
K921141 · LAS
Diagnostic Reagents, Inc.
Toxicology · 38d
Cleared Apr 16, 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · KPS
General Electric Co.
Radiology · 132d
Cleared Apr 16, 1992
DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER
K920327 · DYB
Daig Corp.
Cardiovascular · 90d