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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41257–41280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2013
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE,...
K131224 · GAW
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 16d
Cleared May 15, 2013
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
K120615 · CGA
Alere San Diego Inc. Dba...
Chemistry · 441d
Cleared May 15, 2013
GENESISPLUS
K122493 · GEX
Cutera, Inc.
General & Plastic Surgery · 272d
Cleared May 15, 2013
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
K122777 · KTT
Nutek Orthopaedics, Inc.
Orthopedic · 246d
Cleared May 15, 2013
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
K123542 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 177d
Cleared May 15, 2013
EASYRA CREATININE REAGENT
K123586 · CGX
Medica Corporation
Chemistry · 175d
Cleared May 15, 2013
3F PRO-PICC
K123617 · LJS
Medical Components, Inc.
General Hospital · 173d
Cleared May 15, 2013
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K123800 · DXN
Little Doctor Electronic...
Cardiovascular · 156d
Cleared May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE...
K123930 · LPS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 146d
Cleared CT May 15, 2013
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · DTK
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared May 15, 2013
UCP HOME DRUG SCREENING TEST
K130463 · DKZ
Ucp Biosciences, Inc.
Toxicology · 82d
Cleared CT May 15, 2013
SAUFLON MULTIPURPOSE SOLUTION
K130734 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 58d
Cleared May 14, 2013
HYDROSIL
K122785 · EZD
Rochester Medical Corp.
Gastroenterology & Urology · 245d
Cleared May 14, 2013
VASCULAR CLAMPS
K123077 · DXC
Hebumedical GmbH
Cardiovascular · 225d
Cleared May 14, 2013
ITCLAMP 50
K123551 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 176d
Cleared May 14, 2013
KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
K123912 · JAQ
Spencer Fillmore
Radiology · 146d
Cleared May 14, 2013
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
K123985 · JAD
Sensus Healthcare
Radiology · 139d
Cleared May 14, 2013
SPEED SHIFT
K124022 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 137d
Cleared May 14, 2013
ILIZAROV DRILL TIP WIRES
K130479 · KTT
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 14, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K130729 · LNS
Dornier Medtech Systems
Gastroenterology & Urology · 57d
Cleared May 14, 2013
ATRICLIP GILLINOV-COSGROVE LAA CLIP
K131107 · FZP
AtriCure, Inc.
General & Plastic Surgery · 25d
Cleared CT May 13, 2013
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON...
K120756 · LPL
The Lagado Corp.
Ophthalmic · 426d
Cleared May 13, 2013
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+...
K122013 · DXN
Microlife Corp.
Cardiovascular · 307d
Cleared May 13, 2013
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
K122635 · MAI
Tornier, Inc.
Orthopedic · 257d