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
44017–44040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2012
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
K121028 · BTR
Etview , Ltd.
Anesthesiology · 77d
Cleared Jun 21, 2012
WAVELIGHT FS200 PATIENT INTERFACE 1505
K121031 · GEX
Alcon Research, Ltd.
General & Plastic Surgery · 77d
Cleared Jun 21, 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032 · FPA
Hospira, Inc.
General Hospital · 77d
Cleared Jun 21, 2012
BEAM BRUSH/BEAM APP
K121165 · EFW
Beam Technologies, LLC
Dental · 65d
Cleared Jun 21, 2012
ZOLL PROPAQ XM
K121367 · MHX
ZOLL Medical Corporation
Cardiovascular · 45d
Cleared Jun 21, 2012
AIRTRAQ SP AIRTRAQ AVANT
K121378 · CCW
Prodol Meditec , Ltd.
Anesthesiology · 44d
Cleared Jun 21, 2012
AXERA ACCESS SYSTEM
K121521 · DYB
Arstasis, Inc.
Cardiovascular · 29d
Cleared Jun 21, 2012
VERSAVIT
K121675 · HQE
Synergetics, Inc.
Ophthalmic · 15d
Cleared Jun 20, 2012
TI-MAX X450
K112024 · EFB
Nakanishi, Inc.
Dental · 341d
Cleared Jun 20, 2012
BLUE MOUNTAIN CERVICAL PLATE
K112809 · KWQ
Qualgenix, LLC
Orthopedic · 267d
Cleared Jun 20, 2012
ENDOGATER AVANTAGE CO2 INSUFFLATOR
K113310 · FCX
Byrne Medical, Inc.
Gastroenterology & Urology · 225d
Cleared Jun 20, 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048 · KIF
Drfp , Ltd.
Dental · 166d
Cleared Jun 20, 2012
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
K120418 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 131d
Cleared Jun 20, 2012
X4
K120447 · OMC
Advanced Brain Monitoring, Inc.
Neurology · 127d
Cleared Jun 20, 2012
GYRUS AMCI PK BUTTON ELECTRODE
K120567 · FAS
Gyrus Acmi, Inc.
Gastroenterology & Urology · 114d
Cleared Jun 20, 2012
E.G. SCAN II ESPHAGOSCOPE SYSTEM
K120702 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 104d
Cleared Jun 20, 2012
ABLE-X
K120783 · ION
Im-Able, Ltd.
Physical Medicine · 97d
Cleared Jun 20, 2012
MICROMANIPULATOR SET
K120877 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 89d
Cleared Jun 20, 2012
QFIX RADIOTHERAPY CHAIR
K120916 · JAI
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Jun 20, 2012
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K121403 · CAZ
Teleflex, Inc.
Anesthesiology · 41d
Cleared Jun 20, 2012
ASCEND SHOULDER SYSTEM
K121493 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Jun 20, 2012
BODYFIX SYSTEM
K121530 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 27d
Cleared Jun 20, 2012
CONE-TROL HEMOGLOBIN A1C CONTROL SET
K121534 · JJX
Cone Bioproducts
Chemistry · 27d
Cleared Jun 20, 2012
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
K121588 · JJX
Randox Laboratories, Ltd.
Chemistry · 20d