FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78505–78528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2001
NIDOIL
K012123 · MQL
Nidacon International AB
Obstetrics & Gynecology · 28d
Cleared Aug 03, 2001
1.5T INFINITY TWINSPEED MR SYSTEM
K012200 · LNH
GE Medical Systems
Radiology · 21d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Aug 03, 2001
SOLARA JR. MANUAL WHEELCHAIR
K012370 · IOR
Invacare Corp.
Physical Medicine · 8d
Cleared Aug 02, 2001
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
K010413 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 171d
Cleared Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Aug 02, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
K011382 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 87d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · KTW
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 76d
Cleared Aug 02, 2001
EZ SYRINGE
K011951 · FMF
Owen Mumford, Ltd.
General Hospital · 42d
Cleared Aug 02, 2001
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · OLV
Sensor Medics Corp.
Neurology · 30d
Cleared Aug 01, 2001
CENTRAL VENOUS CATHETER
K003839 · LJS
Boston Scientific Corp
General Hospital · 232d
Cleared Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · GZB
Medtronic Vascular
Neurology · 181d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · JIT
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Aug 01, 2001
THE ALBERTA LENS SM2, SULFOCON B
K010454 · HQD
Progressive Optical Research , Ltd.
Ophthalmic · 167d
Cleared Aug 01, 2001
AUTOMATED WORKCELL CONTROL SOFTWARE
K010500 · JJE
Lab-Interlink, Inc.
Chemistry · 161d
Cleared Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738 · HWC
Orthomatrix, Inc.
Orthopedic · 142d
Cleared Aug 01, 2001
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
K010908 · HCH
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · HCI
Medicon EG
Neurology · 128d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared Aug 01, 2001
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · GAM
Aesculap, Inc.
General & Plastic Surgery · 89d
Cleared Aug 01, 2001
ARTHREX BIO-POST AND WASHER
K011495 · MAI
Arthrex, Inc.
Orthopedic · 78d
Cleared Aug 01, 2001
ORTHO VLC
K011521 · DYH
First Scientific Limited
Dental · 76d
Cleared Aug 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
K011791 · LZA
Latexx Partners Bhd.
General Hospital · 54d