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
42145–42168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · KWQ
Nuvasive, Inc.
Orthopedic · 200d
Cleared Feb 01, 2013
DORNIER MEDILAS H30 SOLVO
K122159 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 196d
Cleared Feb 01, 2013
ICS IMPULSE
K122550 · GWN
Gn Otometrics
Neurology · 164d
Cleared Feb 01, 2013
NOVEL FIT AND FILL STEM
K122853 · MEH
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Feb 01, 2013
VIVIX-S WIRELESS
K122865 · MQB
Vieworks Co., Ltd.
Radiology · 136d
Cleared Feb 01, 2013
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING...
K123033 · DWM
Rocket Medical Plc
Anesthesiology · 126d
Cleared Feb 01, 2013
EASYSPINE SYSTEM
K123134 · NKB
Ldr Spine USA, Inc.
Orthopedic · 119d
Cleared Feb 01, 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 92d
Cleared Feb 01, 2013
SYNGO, BREAST CARE
K123420 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 01, 2013
INVIVO DENTAL
K123519 · LLZ
Anatomage, Inc.
Radiology · 78d
Cleared Feb 01, 2013
EPIEN ROOT CANAL CLEANSER
K123538 · KJJ
Epien Medical, Inc.
Dental · 77d
Cleared Feb 01, 2013
INCORIS TZI
K123545 · EIH
Sirona Dental Systems GmbH
Dental · 74d
Cleared Feb 01, 2013
ANTERIOR CERVICAL PLATE SYSTEM
K123578 · KWQ
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 73d
Cleared Feb 01, 2013
E-CUBE 15
K123610 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 72d
Cleared Feb 01, 2013
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K123757 · LYY
Assurguard Sdn. Bhd.
General Hospital · 56d
Cleared Feb 01, 2013
MICRODOSE SI
K123995 · MUE
Philips Digital Mammography Sweden AB
Radiology · 37d
Cleared Jan 31, 2013
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
K112880 · MYC
Freedom Meditech, Inc.
Ophthalmic · 489d
Cleared Jan 31, 2013
GEMINI STERILZATION WRAP
K113353 · FRG
Medline Industries, Inc.
General Hospital · 444d
Cleared Jan 31, 2013
ULTRASONIC SCALER
K113530 · ELC
Nakanishi, Inc.
Dental · 428d
Cleared Jan 31, 2013
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122396 · LYZ
Wealth on (Jiangsu) Co., Ltd.
General Hospital · 177d
Cleared Jan 31, 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · LZA
Cardinal Health, Inc.
General Hospital · 149d
Cleared Jan 31, 2013
V8 TRANSLUMINAL BAV CATHETER
K123111 · OZT
Intervalve, Inc.
Cardiovascular · 120d
Cleared Jan 31, 2013
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC...
K123196 · MSD
Covidien
Gastroenterology & Urology · 112d
Cleared Jan 31, 2013
THE ADVANCE CATHETER FOR HSG AND SIS
K123258 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 105d