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
58513–58536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2007
CA, MODEL: CAM
K071250 · OBO
Optovue, Inc.
Ophthalmic · 147d
Cleared Sep 28, 2007
FITMATE SERIES
K071533 · BZL
Cosmed Srl
Anesthesiology · 115d
Cleared Sep 28, 2007
QXT EXTRACTION CATHETER
K071727 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 95d
Cleared Sep 28, 2007
DEPUY DELTA TS CERAMIC FEMORAL HEADS
K071830 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Sep 28, 2007
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
K071845 · KAM
Acclarent, Inc.
General & Plastic Surgery · 85d
Cleared Sep 28, 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 78d
Cleared Sep 28, 2007
SPACER
K072069 · EBF
Vericom Co., Ltd.
Dental · 60d
Cleared Sep 28, 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 27, 2007
RELIANCE VBS SYSTEM
K063637 · MQP
Reliance Medical Systems, LLC
Orthopedic · 294d
Cleared Sep 27, 2007
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
K063838 · DFC
Thermo Electron OY
Chemistry · 275d
Cleared Sep 27, 2007
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13,...
K071578 · QSY
Lifescience Plus, Inc.
General & Plastic Surgery · 111d
Cleared Sep 27, 2007
I45, I45S, I60, AND I60S
K071708 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 98d
Cleared Sep 27, 2007
OMNIWAVE ENDOVASCULAR SYSTEM
K071762 · QEY
Omnisonics Medical Technologies
Cardiovascular · 90d
Cleared Sep 27, 2007
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K071800 · HGM
Philips Medizinsysteme Boeblingen...
Obstetrics & Gynecology · 87d
Cleared Sep 27, 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · JDS
Synthes (Usa)
Orthopedic · 58d
Cleared Sep 27, 2007
MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K072413 · NBW
Agamatrix
Chemistry · 30d
Cleared Sep 27, 2007
ENSEAL TISSUE SEALING DEVICE
K072493 · GEI
Surgrx, Inc.
General & Plastic Surgery · 22d
Cleared Sep 26, 2007
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156 · DSB
Cardiodynamics International Corp.
Cardiovascular · 252d
Cleared Sep 26, 2007
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
K070339 · FLL
Cincinnati Sub-Zero Products, Inc.
General Hospital · 233d
Cleared Sep 26, 2007
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · FHN
Sapimed S.P.A.
Gastroenterology & Urology · 180d
Cleared Sep 26, 2007
P.004 NC ANATOMIC ABUTMENTS
K071357 · NHA
Institut Straumann AG
Dental · 134d
Cleared Sep 26, 2007
P.004 ABUTMENTS
K071919 · NHA
Straumann USA (On Behalf of Institut...
Dental · 76d
Cleared Sep 26, 2007
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
K071962 · HCG
Cordis Neurovascular, Inc.
Neurology · 72d
Cleared Sep 26, 2007
MIM 4.1 (SEASTAR)
K071964 · LLZ
Mimvista Corp.
Radiology · 72d