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
68113–68136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2004
CHIN-UP STRIP
K040491 · LWF
Dale Miller, Inc. - the Chin-Up Company
Ear, Nose, Throat · 197d
Cleared Sep 10, 2004
BD FACSCANTO SYSTEM
K040725 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 172d
Cleared Sep 10, 2004
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND...
K041285 · GEI
Gyrus Medical , Ltd.
General & Plastic Surgery · 120d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · LYA
Medtronic Xomed, Inc.
Ear, Nose, Throat · 108d
Cleared Sep 10, 2004
QUICKSCREEN, MODELS 9177X AND 9178X
K041578 · LCM
Phamatech
Chemistry · 88d
Cleared Sep 10, 2004
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
K041791 · NQJ
Chf Solutions, Inc.
Gastroenterology & Urology · 70d
Cleared Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · MMI
Abbott Laboratories
Chemistry · 66d
Cleared Sep 10, 2004
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A,...
K041867 · NLF
Hygia Health Services, Inc.
Anesthesiology · 63d
Cleared Sep 10, 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · LPH
Exactech, Inc.
Orthopedic · 57d
Cleared Sep 10, 2004
VARILITE LASER SYSTEM
K041930 · GEX
Iridex Corporation
General & Plastic Surgery · 53d
Cleared Sep 10, 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Sep 10, 2004
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412,...
K042202 · FLL
Oriental System Technology, Inc.
General Hospital · 28d
Cleared Sep 10, 2004
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K042225 · FAJ
Acmi Corporation
Gastroenterology & Urology · 24d
Cleared Sep 10, 2004
INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
K042262 · CAW
Sequal Technologies, Inc.
Anesthesiology · 18d
Cleared Sep 10, 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · LCX
Unipath , Ltd.
Chemistry · 18d
Cleared Sep 10, 2004
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
K042294 · BZD
Suiter Enterprises, Inc.
Anesthesiology · 17d
Cleared Sep 09, 2004
M.L. PRIMER
K040079 · KLE
Shofu Dental Corp.
Dental · 238d
Cleared Sep 09, 2004
STERITEC EMU-GRAPH, MODEL NO. CI 131/US
K040901 · JOJ
Steritec Products, Inc.
General Hospital · 155d
Cleared Sep 09, 2004
CADDY
K041186 · ITI
Afikim Electric Vehicles
Physical Medicine · 126d
Cleared Sep 09, 2004
CRANIAL HELMET
K041215 · MVA
Otto Bock Healthcare LP
Neurology · 122d
Cleared Sep 09, 2004
RANDOX TRI LEVEL CARDIAC CONTROL
K041361 · JJY
Randox Laboratories Limited
Chemistry · 111d
Cleared Sep 09, 2004
PREMICATH, 1261.205
K041468 · LJS
Vygon Corp.
General Hospital · 99d
Cleared Sep 09, 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743 · DKZ
ACON Laboratories, Inc.
Toxicology · 73d
Cleared Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764 · LCP
Ortho-Clinical Diagnostics
Chemistry · 71d