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
49345–49368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX
Roche Diagnostics Corp.
Immunology · 141d
Cleared Oct 05, 2010
XTRA AUTOTRANSFUSION SYSTEM
K101586 · CAC
Sorin Group Italia S.R.L.
Anesthesiology · 120d
Cleared Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657 · KGE
Boston Scientific Corp
Gastroenterology & Urology · 116d
Cleared Oct 05, 2010
MIE SCINTRON GAMMA CAMERA SYSTEMS
K101768 · KPS
Miegmbh
Radiology · 104d
Cleared Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
K101809 · JJY
Fujirebio Diagnostics,Inc.
Immunology · 98d
Cleared Oct 05, 2010
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
K101813 · LNH
Imris, Inc.
Radiology · 98d
Cleared Oct 05, 2010
ELECSYS CEA CALCHECK 5
K101856 · JJX
Roche Diagnostics
Immunology · 96d
Cleared Oct 05, 2010
GE LOGIQ P6/P6 PRO
K101874 · IYN
Ge Healthcare
Radiology · 95d
Cleared Oct 05, 2010
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · HSX
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Oct 05, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 61d
Cleared Oct 05, 2010
SYNGO DYNAMICS, VERSION 9.0
K102150 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Oct 05, 2010
GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
K102256 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 56d
Cleared Oct 05, 2010
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · DSY
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Oct 04, 2010
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
K092723 · HRX
Skeletal Dynamics, LLC
Orthopedic · 395d
Cleared Oct 04, 2010
LUMANOSITY CELEBRITY, MODEL 204
K100213 · ILY
Lumanosity, Inc.
Physical Medicine · 252d
Cleared Oct 04, 2010
CASPIAN SPINAL SYSTEM
K101084 · KWP
K2m, Inc.
Orthopedic · 168d
Cleared Oct 04, 2010
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL...
K101598 · KKX
Exact Medical Manufacturing, Inc.
General Hospital · 118d
Cleared Oct 04, 2010
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH...
K101828 · LYY
Gx Corporation Sdn Bhd
General Hospital · 95d
Cleared Oct 04, 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · DQA
GE Healthcare Finland Oy
Anesthesiology · 90d
Cleared Oct 04, 2010
KAIYANG ALUMINUM WHEELCHAIR
K101998 · IOR
Guangdong Kaiyang Medical Technology...
Physical Medicine · 81d
Cleared Oct 04, 2010
KAIYANG STEEL WHEELCHAIR
K101999 · IOR
Guangdong Kaiyang Medical Technology...
Physical Medicine · 81d
Cleared Oct 04, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K102096 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 69d
Cleared Oct 04, 2010
STRETCH VINYL EXAMINATION GLOVE POWDER FREE
K102160 · LYZ
Shandong Blue Sail Innovation Co., Ltd.
General Hospital · 63d
Cleared Oct 04, 2010
ZIP'R MANTIS POWERED WHEELCHAIR
K102355 · ITI
Global Fabtech Wheelchair (Shanghai)...
Physical Medicine · 46d