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

Filters: Cleared only ×
176,076 results
66553–66576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 69d
Cleared Mar 07, 2005
ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE
K050052 · NHA
Atlantis Components, Inc.
Dental · 56d
Cleared Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275 · HTY
Inion , Ltd.
Orthopedic · 28d
Cleared Mar 07, 2005
DIVER C.E. CATHETER
K050276 · QEZ
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 28d
Cleared Mar 04, 2005
NEUROTECH KNEEHAB
K024258 · IPF
Bio-Medical Research, Ltd.
Physical Medicine · 802d
Cleared Mar 04, 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · BZD
Salter Labs
Anesthesiology · 400d
Cleared Mar 04, 2005
MILTEX LAPAROSCOPIC INSTRUMENTS
K043013 · HET
Miltex, Inc.
Obstetrics & Gynecology · 122d
Cleared Mar 04, 2005
DEPUY CAS KNEE INSTRUMENTATION
K043223 · HAW
DePuy Orthopaedics, Inc.
Neurology · 102d
Cleared Mar 04, 2005
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100
K043331 · FLL
Hubdic Co., Ltd.
General Hospital · 92d
Cleared Mar 04, 2005
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
K043357 · LKD
Linde Medical Sensors AG
Anesthesiology · 88d
Cleared Mar 04, 2005
FUSION PUTTY TYPE
K043493 · ELW
GC America, Inc.
Dental · 77d
Cleared Mar 04, 2005
FEATHERLIFT EXTENDED APTOS THREAD
K043591 · GAW
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 66d
Cleared Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · KTT
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Mar 04, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050175 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 37d
Cleared Mar 04, 2005
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
K050186 · DKZ
Ameditech, Inc.
Toxicology · 36d
Cleared Mar 04, 2005
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · JEY
Synthes (Usa)
Dental · 35d
Cleared Mar 04, 2005
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
K050205 · KRA
Flowmedica, Inc.
Cardiovascular · 35d
Cleared Mar 04, 2005
CONTOUR NECKLIFT THREADS
K050247 · GAW
Surgical Specialties Corp
General & Plastic Surgery · 30d
Cleared Mar 04, 2005
BARI-KAD PACKING DEVICE
K050318 · EIE
Bioenvelop Agro, Inc.
Dental · 23d
Cleared Mar 04, 2005
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
K050338 · JIH
Akers Biosciences, Inc.
Chemistry · 21d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Mar 04, 2005
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
K050413 · DXN
Amplife Corporation
Cardiovascular · 14d
Cleared Mar 03, 2005
LAZRPULSR 4X
K041565 · NHN
Led Healing Light, LLC
Physical Medicine · 266d