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
66169–66192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2005
SURPASSON P5 NEWTRON
K050895 · ELC
Satelec
Dental · 12d
Cleared Apr 19, 2005
KOLIBRI SPINE
K042721 · HAW
Brainlab AG
Neurology · 200d
Cleared Apr 19, 2005
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
K050165 · GEX
Cyden Limited
General & Plastic Surgery · 84d
Cleared Apr 19, 2005
GROOVY IMPLANTS
K050258 · DZE
Nobel Biocare AB
Dental · 75d
Cleared Apr 19, 2005
FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
K050695 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 32d
Cleared Apr 18, 2005
DOLPHIN INFLATION DEVICE
K042449 · MAV
Sedat S.A.
Cardiovascular · 221d
Cleared Apr 18, 2005
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
K043083 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 161d
Cleared Apr 18, 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · HTY
Xtremi-T, LLC
Orthopedic · 136d
Cleared Apr 18, 2005
WAGNER SL REVISION STEM LATERAL
K043356 · LZO
Zimmer Austin, Inc.
Orthopedic · 133d
Cleared Apr 18, 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 117d
Cleared Apr 18, 2005
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN...
K050122 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 89d
Cleared Apr 18, 2005
BARDPORT TITANIUM PORTS
K050310 · LJT
Bard Access Systems, Inc.
General Hospital · 69d
Cleared Apr 18, 2005
ONTRAK TESTCARD 9
K050321 · DIO
Varian, Inc.
Toxicology · 68d
Cleared Apr 18, 2005
NOVEL VBR SPINAL SYSTEM
K050553 · MQP
Alphatec/Nexmed
Orthopedic · 46d
Cleared Apr 18, 2005
LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
K050707 · IOR
Lerado Oversea Ltd. Twn Branch (Bvi)
Physical Medicine · 31d
Cleared Apr 18, 2005
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
K050724 · ITX
C.R. Bard, Inc.
Radiology · 28d
Cleared Apr 15, 2005
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
K041495 · FPA
Pentaferte S.P.A
General Hospital · 315d
Cleared Apr 15, 2005
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM,...
K042018 · FIP
Simply Clean Air & Water, Inc.
Gastroenterology & Urology · 262d
Cleared Apr 15, 2005
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
K042927 · PJE
Greiner Bio-One Vacuette North America
Chemistry · 175d
Cleared Apr 15, 2005
HOME-AWAY SYSTEM, MODEL 1041
K042944 · CAW
In-X Corporation
Anesthesiology · 172d
Cleared Apr 15, 2005
TOMAS PIN
K042965 · OAT
Dentaurum, Inc.
Dental · 170d
Cleared Apr 15, 2005
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K043250 · KKY
Stryker Leibinger
General & Plastic Surgery · 143d
Cleared Apr 15, 2005
MICROFLO-SAFE SCALP VEIN SET
K043328 · FPA
Dks Loversan Industria Biomedica Spa
General Hospital · 134d
Cleared Apr 15, 2005
P&P SAFETY SYRINGE
K043419 · MEG
Medexel Medical Mfg. Co., Ltd.
General Hospital · 123d