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
72769–72792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 09, 2003
BD INSULIN SYRINGE
K024112 · FMF
Becton, Dickinson & CO
General Hospital · 27d
Cleared Jan 09, 2003
QWH-250-PAN WRIST ARRAY COIL
K024209 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Jan 09, 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH...
K024292 · LYY
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Jan 09, 2003
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
K024352 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 09, 2003
PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS
K024354 · MOS
Mri Devices Corp.
Radiology · 10d
Cleared Jan 08, 2003
LAD, MODEL LAD-01
K021222 · GEX
Norwood Abbey , Ltd.
General & Plastic Surgery · 266d
Cleared Jan 08, 2003
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
K021694 · DTQ
Cardiovention, Inc.
Cardiovascular · 231d
Cleared Jan 08, 2003
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
K022272 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 177d
Cleared Jan 08, 2003
MICROVISION SCLERAL BUCKLING COMPONENTS
K023481 · HQX
Microvision, Inc.
Ophthalmic · 83d