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
74809–74832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2002
QUANTIM 16 AUTOCLAVE
K021064 · FLE
Scican
General Hospital · 128d
Cleared Aug 08, 2002
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K021143 · LPN
Alcon Universal, Ltd.
Ophthalmic · 121d
Cleared Aug 08, 2002
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
K021538 · HQF
Lightmed Corp.
Ophthalmic · 90d
Cleared Aug 08, 2002
OSA RIGID INTERNAL FIXATION SYSTEM
K021618 · JEY
Osteomed Corp.
Dental · 84d
Cleared Aug 08, 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · DYB
Arrow Intl., Inc.
Cardiovascular · 76d
Cleared Aug 08, 2002
ADAPT OPEN ACCESS PORT, MODEL 41233
K021731 · GCJ
Taut, Inc.
General & Plastic Surgery · 76d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 08, 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107 · DRN
Cardiomedics, Inc.
Cardiovascular · 41d
Cleared Aug 08, 2002
LAMITRODE S-SERIES (S4 AND S8) LEADS
K022222 · GZB
Advanced Neuromodulation System,Inc
Neurology · 30d
Cleared Aug 08, 2002
AART SILICONE SHEETING
K022223 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 30d
Cleared Aug 08, 2002
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K022305 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 23d
Cleared Aug 08, 2002
ACTIBAND
K022404 · ILX
Paw, LLC
Physical Medicine · 16d
Cleared Aug 08, 2002
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE,...
K022426 · JKA
Becton, Dickinson & CO
Chemistry · 14d
Cleared Aug 07, 2002
ALPHA DRIVE SYSTEM
K013396 · HAW
Alpha Omega , Ltd.
Neurology · 296d
Cleared Aug 07, 2002
ULTIMA SNORING MIKE, MODEL 0540
K020312 · MNR
Braebon Medical Corp.
Anesthesiology · 189d
Cleared Aug 07, 2002
800 SERIES EASYNEB NEBULIZER
K020357 · CAF
Nellcor Puritan Bennett, Inc.
Anesthesiology · 184d
Cleared Aug 07, 2002
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
K021492 · NUC
Personal Products Co., Div. of Mcneil...
Obstetrics & Gynecology · 90d
Cleared Aug 07, 2002
OPUSDUO EC DENTAL LASER SYSTEM
K021508 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 90d
Cleared Aug 07, 2002
MDA D-DIMER
K021877 · GHH
bioMerieux, Inc.
Hematology · 61d
Cleared Aug 07, 2002
COAMATIC AT-400
K022195 · JBQ
Instrumentation Laboratory CO
Hematology · 33d
Cleared Aug 06, 2002
PRISMA SYSTEM
K010805 · KDI
Gambro Renal Products
Gastroenterology & Urology · 508d
Cleared Aug 06, 2002
LODOX, MODEL BASELINE
K013999 · JAK
Lodox Systems (Pty), Ltd.
Radiology · 245d
Cleared Aug 06, 2002
EASYTEM EAR THERMOMETER, MODEL BT-020
K020520 · FLL
Metatech Co., Ltd.
General Hospital · 168d
Cleared Aug 06, 2002
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
K020897 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 140d