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
51745–51768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2009
SKYLINE 55, MODEL VER 1
K092153 · MWI
Larsen & Toubro Limited
Cardiovascular · 127d
Cleared Nov 20, 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · HRS
Howmedica Osteonics Corp.
Orthopedic · 122d
Cleared Nov 20, 2009
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
K092498 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 98d
Cleared Nov 20, 2009
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE...
K092499 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 98d
Cleared Nov 20, 2009
ACU007S
K092522 · KXK
Oncology Systems, Inc.
Radiology · 94d
Cleared Nov 20, 2009
ORTHOPANTOMOGRAPH OP30
K092591 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 88d
Cleared Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607 · PAH
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 20, 2009
MICRUS MICROCATHETER, MODEL COURIER 270
K092702 · DQO
Micrus Endovascular Corporation
Cardiovascular · 79d
Cleared Nov 20, 2009
COSMEDENT BRUSHABLE COMPOSITE
K092730 · EBF
Cosmedent, Inc.
Dental · 77d
Cleared Nov 20, 2009
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
K092868 · JOY
CellaVision AB
Hematology · 63d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 20, 2009
SCOUTPRO 7F LONG CATHETERS
K093303 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Nov 20, 2009
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
K093451 · GEX
Omniguide, Inc.
General & Plastic Surgery · 15d
Cleared Nov 20, 2009
SONIX ULTRASOUND SCANNER
K093462 · ITX
Ultrasonix Medical Corporation
Radiology · 14d
Cleared Nov 20, 2009
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · IYO
Aloka Co., Ltd.
Radiology · 10d
Cleared Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
K093512 · KNW
Senorx, Inc.
Gastroenterology & Urology · 7d
Cleared Nov 19, 2009
MICRODOT XTRA
K083273 · NBW
Cambridge Sensors Limited
Chemistry · 378d
Cleared Nov 19, 2009
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
K090682 · KDI
Edwards Lifesciences Services GmbH
Gastroenterology & Urology · 248d
Cleared Nov 19, 2009
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K091263 · JWH
Materialise NV
Orthopedic · 203d
Cleared Nov 19, 2009
IMMUNOSCAN CCPLUS
K091657 · NHX
Euro-Diagnostica AB
Immunology · 163d
Cleared Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · JXG
Integra Lifesciences Corp.
Neurology · 106d
Cleared Nov 19, 2009
KRD1 PEDICLE SCREW SYSTEM
K092420 · MNI
Spinefrontier, Inc.
Orthopedic · 105d
Cleared Nov 19, 2009
ENDOGATOR
K092429 · FEQ
Byrne Medical, Inc.
Gastroenterology & Urology · 104d
Cleared Nov 19, 2009
RADAR VASCULAR COMPRESSION DEVICES
K092503 · DXC
Advanced Vascular Dynamics
Cardiovascular · 97d