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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
41761–41784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2013
MALLEABLE TIP ENDOSCOPIC APPLICATOR
K123847 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 25d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION...
K123868 · FPA
Baxter Healthcare Corp
General Hospital · 22d
Cleared Jan 07, 2013
TS IMPLANT SYSTEM
K121585 · DZE
Osstem Implant Co., Ltd.
Dental · 221d
Cleared Jan 07, 2013
AVIE TOTAL HB TEST SYSTEM
K121752 · GKR
Mec Dynamics Corp
Hematology · 207d
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991 · OAH
Advandx, Inc.
Microbiology · 185d
Cleared Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
K122288 · OBP
Brainsway , Ltd.
Neurology · 161d
Cleared Jan 07, 2013
VANTAGE MODEL V5000, V5100, V5000C, V5100C
K122643 · MUH
Midmark Corp.
Radiology · 131d
Cleared Jan 04, 2013
THERASOM-CAST
K113516 · LRK
Family Dental Services, P.C.
Dental · 402d
Cleared Jan 04, 2013
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K113787 · MKJ
Defibtech, LLC
Cardiovascular · 379d
Cleared Jan 04, 2013
INSTINCT JAVA SYSTEM
K122592 · MNH
Zimmer Spine
Orthopedic · 133d
Cleared Jan 04, 2013
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
K122818 · KCT
Olympus Keymed (Medical & Industrial...
General Hospital · 112d
Cleared Jan 04, 2013
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
K122854 · DYB
Arrow International (Subsidiary of...
Cardiovascular · 108d
Cleared Jan 04, 2013
BODY FAT SCALE MODEL SF-371
K122976 · MNW
Shenzhen Belter Health Measurement...
Gastroenterology & Urology · 100d
Cleared Jan 04, 2013
K7C SPACER
K123388 · ODP
K7, LLC
Orthopedic · 63d
Cleared Jan 04, 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING...
K123731 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 30d
Cleared Jan 03, 2013
COLLADENTAL BARRIER
K100695 · NPL
Collamatrix, Inc.
Dental · 1029d
Cleared Jan 03, 2013
DOPPLEX ABILITY
K121108 · JOM
Huntleigh Healthcare
Cardiovascular · 266d
Cleared Jan 03, 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 182d
Cleared Jan 03, 2013
BIOPHOTAS LIFELIGHT
K122237 · ILY
Biophotas, Inc.
Physical Medicine · 161d
Cleared Jan 03, 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483 · LZG
Asante Solutions, Inc.
General Hospital · 142d
Cleared Jan 03, 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · DPT
Moor Instruments, Ltd.
Cardiovascular · 101d
Cleared Jan 03, 2013
SOVEREIGN MINI
K123102 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 93d
Cleared Jan 03, 2013
JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
K123194 · DXC
North American Rescue Products, Inc.
Cardiovascular · 84d
Cleared Jan 03, 2013
SUPER STAPLE(TM) CLASSIC
K123363 · JDR
Metric Medical Devices, Inc.
Orthopedic · 63d