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
60073–60096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K063627 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 104d
Cleared Mar 20, 2007
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
K063863 · DXQ
Advantage Medical Cables, Inc.
Cardiovascular · 82d
Cleared Mar 20, 2007
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER
K070011 · DQO
Irvine Biomedical,Inc.(Ibi)
Radiology · 76d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · CEW
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 20, 2007
ISIS
K070482 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 28d
Cleared Mar 20, 2007
SPIROS
K070532 · FPA
Icu Medical, Inc.
General Hospital · 22d
Cleared Mar 20, 2007
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
K070588 · MHX
Philips Medical Systems
Cardiovascular · 19d
Cleared Mar 20, 2007
C.T.M. MOBILITTY SCOOTER # HS-295
K070603 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 15d
Cleared Mar 19, 2007
REPROCESSED PHACOEMULSIFICATION TIPS
K060648 · NKX
Alliance Medical Corp.
Ophthalmic · 371d
Cleared Mar 19, 2007
POWDER FREE NITRILE BLUE EXAMINATION GLOVE
K061504 · LZA
Liwe Trading
General Hospital · 291d
Cleared Mar 19, 2007
NIO 5MP-21 AND MDNG-5121 CB
K062621 · LLZ
Barcoview
Radiology · 195d
Cleared Mar 19, 2007
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
K063150 · CZW
Thermo Electron OY
Immunology · 154d
Cleared Mar 19, 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · MMI
Dade Behring, Inc.
Chemistry · 90d
Cleared Mar 19, 2007
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K063866 · LIP
Bio-Rad Laboratories
Microbiology · 80d
Cleared Mar 19, 2007
MEMOMETAL MEMORY STAPLES
K070031 · JDR
Memometal Technologies
Orthopedic · 75d
Cleared Mar 19, 2007
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
K070033 · JDR
Memometal Technologies
Orthopedic · 75d
Cleared Mar 19, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070188 · LYZ
Hong DI Plastic Products Co., Ltd.
General Hospital · 56d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · JJY
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 19, 2007
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
K070342 · FLL
American I.V. Products, Inc.
General Hospital · 41d
Cleared Mar 19, 2007
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420 · ODD
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 19, 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · FRO
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Mar 19, 2007
SILVERLON ADHESIVE STRIP
K984205 · FRO
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Mar 19, 2007
SILVERLON DIRECT PRESSURE WOUND DRESSING
K984207 · KMF
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Mar 16, 2007
ATRILAZE MI SURGICAL ABLATION SYSTEM
K061489 · GEX
Medical Cv, Inc.
General & Plastic Surgery · 289d