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
43849–43872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2012
M/29TM - PRESSURE INJECTABLE
K111939 · FOZ
Flexicath , Ltd.
General Hospital · 369d
Cleared Jul 11, 2012
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
K112010 · NVP
Trudell Medical Intl.
Anesthesiology · 363d
Cleared Jul 11, 2012
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
K112748 · KWQ
Spinal USA, LLC
Orthopedic · 294d
Cleared Jul 11, 2012
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR...
K113349 · DAE
The Binding Site Group , Ltd.
Immunology · 240d
Cleared Jul 11, 2012
MINICAT
K113421 · JAK
Xoran Technologies, Inc.
Radiology · 236d
Cleared Jul 11, 2012
MONGOOSE ANGIOGRAPHIC CATHETER
K113819 · DQO
Pediacath, Inc.
Cardiovascular · 197d
Cleared Jul 11, 2012
MEDSOURCE IV ADMINSTRATION SET
K120424 · LHI
Medsource International, LLC
General Hospital · 149d
Cleared Jul 11, 2012
POISE PERSONAL LUBRICANT
K120650 · NUC
Kimberly Clark Corporation
Obstetrics & Gynecology · 131d
Cleared Jul 11, 2012
AC LENS BRANDED CONTACT LENS CASE
K120969 · LRX
Arlington Contact Lens Services,Inc.
Ophthalmic · 103d
Cleared Jul 11, 2012
RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
K121746 · JJX
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jul 11, 2012
LIQUICHEK URINE CHEMISTRY CONTROL
K121794 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 22d
Cleared Jul 11, 2012
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K121838 · MQB
Liebel-Flarsheim
Radiology · 19d
Cleared Jul 11, 2012
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
K121856 · LIT
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Jul 10, 2012
STATIM 2000 G4 CASSETTE
K112872 · FLE
Scican , Ltd.
General Hospital · 284d
Cleared Jul 10, 2012
VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K120263 · MUH
Genoray Co., Ltd.
Radiology · 162d
Cleared Jul 10, 2012
GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
K120474 · KCT
Gyrus Acmi, Inc.
General Hospital · 145d
Cleared Jul 10, 2012
POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
K120584 · LYZ
Wealth on (Jiangsu) Co., Ltd.
General Hospital · 134d
Cleared Jul 10, 2012
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · CBK
Respironics, Inc.
Anesthesiology · 130d
Cleared Jul 10, 2012
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
K120773 · DQA
Covidien, LLC
Anesthesiology · 118d
Cleared Jul 10, 2012
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
K121133 · NBW
I-Sens, Inc.
Chemistry · 88d
Cleared Jul 10, 2012
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
K121426 · GEI
Synergetics, Inc.
General & Plastic Surgery · 57d
Cleared Jul 10, 2012
DIRECTPATH
K121449 · LLZ
Cybernet Systems Co., Ltd.
Radiology · 56d
Cleared Jul 10, 2012
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
K121471 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 53d
Cleared Jul 10, 2012
V5MS TRANSDUCER
K121807 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 20d