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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54265–54288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2009
ZEGRA POSTURE TRAINER
K081540 · LZW
Peter Fischer
Physical Medicine · 263d
Cleared Feb 20, 2009
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · NBW
U. S. Diagnostics, Inc.
Chemistry · 199d
Cleared Feb 20, 2009
FLOWTAIN & FLOWTAIN LV
K083051 · DYH
Reliance Orthodontic Products, Inc.
Dental · 129d
Cleared Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 109d
Cleared Feb 20, 2009
ICS CHARTR EP 200
K083399 · GWJ
Gn Otometrics A/S
Neurology · 95d
Cleared Feb 20, 2009
PERIOGENIX
K083516 · EMA
Oroscience, Inc.
Dental · 86d
Cleared Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Feb 20, 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · JIX
Siemens Healthcare Diagnostics
Chemistry · 78d
Cleared Feb 20, 2009
STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
K083727 · DQX
Bridgepoint Medical
Cardiovascular · 67d
Cleared Feb 20, 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 63d
Cleared Feb 20, 2009
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND...
K083786 · FPD
Corpak Medsystems
Gastroenterology & Urology · 63d
Cleared Feb 20, 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · FGE
Cook, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 20, 2009
EVICEL APPLICATION DEVICE
K090162 · FMF
Omrix Biopharmaceuticals , Ltd.
General Hospital · 29d
Cleared Feb 20, 2009
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
K090177 · MQV
Inion OY
Orthopedic · 28d
Cleared Feb 20, 2009
GAMMA-BSM, BETA-BSM
K090242 · MQV
Etex Corp.
Orthopedic · 18d
Cleared Feb 20, 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 10d
Cleared Feb 19, 2009
CARDITTE MICROTEL
K082124 · DPS
Et Medical Devices Spa
Cardiovascular · 206d
Cleared Feb 19, 2009
PRESCISION OPTION
K082775 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 150d
Cleared Feb 19, 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 133d
Cleared Feb 19, 2009
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
K083488 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 86d
Cleared Feb 19, 2009
NEUROSCAPE
K083491 · LLZ
Olea Medical
Radiology · 86d
Cleared Feb 19, 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE...
K083497 · HSB
Zimmer, Inc.
Orthopedic · 86d
Cleared Feb 19, 2009
MODIFICATION TO AUTO-BAND LIGATOR
K083556 · MND
Scandimed International
Gastroenterology & Urology · 79d
Cleared Feb 19, 2009
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
K083600 · LYZ
Quantum Co., Ltd.
General Hospital · 76d