Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69337–69360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2004
STRAUMANN GRANULES
K040646 · LYC
The Straumann Co.
Dental · 53d
Cleared May 03, 2004
CERAFORM BONE VOID FILLER
K040669 · MQV
Teknimed, S.A.
Orthopedic · 49d
Cleared May 03, 2004
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
K040856 · MPO
Rapid Aid , Ltd.
Physical Medicine · 31d
Cleared May 03, 2004
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
K040936 · FQM
Leda Co., Ltd.
General Hospital · 24d
Cleared May 03, 2004
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
K041025 · INI
Golden Technologies, Inc.
Physical Medicine · 12d
Cleared Apr 30, 2004
PERFECT SAFETY SYRINGE
K030604 · MEG
Perfect Medical Industry Co., Ltd.
General Hospital · 430d
Cleared Apr 30, 2004
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K031687 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 333d
Cleared Apr 30, 2004
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
K033077 · FLL
Metatech Co., Ltd.
General Hospital · 214d
Cleared Apr 30, 2004
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
K033198 · ELC
Apoza Enterprise Co., Ltd.
Dental · 211d
Cleared Apr 30, 2004
SONA PILLOW
K040161 · MYB
Sleep Devices, Inc.
Ear, Nose, Throat · 98d
Cleared Apr 30, 2004
QUANTUM CEMENT RESTRICTOR
K040276 · JDK
Quantum Orthopedics
Orthopedic · 85d
Cleared Apr 30, 2004
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
K040289 · GEX
Cynosure, Inc.
General & Plastic Surgery · 84d
Cleared Apr 30, 2004
RIVA LUTING
K040393 · EMA
Southern Dental Industries, Inc.
Dental · 73d
Cleared Apr 30, 2004
THE STRAUMANN ORTHO IMPLANT SYSTEM
K040469 · OAT
The Straumann Co.
Dental · 66d
Cleared Apr 30, 2004
MOBILE OXYGEN STORAGE TANK (MOST)
K040738 · CAW
Pacific Consolidated Industries Llp
Anesthesiology · 39d
Cleared Apr 30, 2004
AXSYM CYCLOSPORINE
K040761 · MKW
Abbott Laboratories, Inc.
Chemistry · 36d
Cleared Apr 30, 2004
PANALOK LOOP ANCHOR
K040827 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 31d
Cleared Apr 30, 2004
SENORX BIOPSY DEVICE II
K040842 · KNW
Senorx, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · GGP
Instrumentation Laboratory CO
Hematology · 29d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · DQX
Boston Scientific Corp
Cardiovascular · 28d
Cleared Apr 30, 2004
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · FRN
Medex, Inc.
General Hospital · 24d
Cleared Apr 30, 2004
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
K040968 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 16d
Cleared Apr 29, 2004
VERSABOND AB BONE CEMENT
K022688 · LOD
Smith & Nephew, Inc.
Orthopedic · 625d
Cleared Apr 29, 2004
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
K032568 · DXQ
Med Textile, LLC
Cardiovascular · 253d