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
73273–73296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · LCP
Randox Laboratories, Ltd.
Chemistry · 66d
Cleared Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · LKJ
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231 · DHN
Bio-Rad
Immunology · 21d
Cleared Jan 13, 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · LHI
Abbott Laboratories
General Hospital · 21d
Cleared Jan 10, 2003
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
K021739 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 227d
Cleared Jan 10, 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · DRN
Sola Medical Devices, LLC
Cardiovascular · 198d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · DXT
Medrad, Inc.
Cardiovascular · 108d
Cleared Jan 10, 2003
BONART ART-L2 LIGHT CURING UNIT
K023721 · EBZ
Bonart Co., Ltd.
Dental · 66d
Cleared Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT...
K023791 · LPL
Softfocal Company, Inc.
Ophthalmic · 58d
Cleared Jan 10, 2003
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K024083 · LZA
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 30d
Cleared Jan 10, 2003
A-SCAN 100
K024114 · IYO
Ophthalmic Technologies, Inc.
Radiology · 28d
Cleared Jan 10, 2003
DUAL-LUMEN CATHETER
K024165 · EOQ
Bistech, Inc.
Ear, Nose, Throat · 24d
Cleared Jan 10, 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · LKJ
Bio-Rad
Immunology · 18d
Cleared Jan 09, 2003
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
K020784 · DWF
Jostra AG
Cardiovascular · 304d
Cleared Jan 09, 2003
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
K020863 · DQK
Biosense Webster, Inc.
Cardiovascular · 297d
Cleared Jan 09, 2003
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634 · CAE
King Systems Corp.
Anesthesiology · 237d
Cleared Jan 09, 2003
CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
K022622 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 155d
Cleared Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 128d
Cleared Jan 09, 2003
PACSPLUS
K023460 · LLZ
Medical Standard Co., Ltd.
Radiology · 86d
Cleared Jan 09, 2003
REMECURE MODEL CL 15E
K023652 · EBZ
Remedent NV
Dental · 71d
Cleared Jan 09, 2003
PERFORMA STEREO
K023864 · IZH
Instrumentarium Corp. Imaging Division
Radiology · 50d
Cleared Jan 09, 2003
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
K023960 · DXG
Lidco, Ltd.
Cardiovascular · 41d
Cleared Jan 09, 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared Jan 09, 2003
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K024095 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 28d