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
67225–67248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2004
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
K042239 · LZA
Pt. Mandiri Inti Buana
General Hospital · 120d
Cleared Dec 16, 2004
EMG MODEL SUA01 SUCTION UNIT
K042349 · JCX
Emg Technology Co., Ltd.
General & Plastic Surgery · 108d
Cleared Dec 16, 2004
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
K042805 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 65d
Cleared Dec 16, 2004
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258 · KNT
Teleflex Medical
Gastroenterology & Urology · 22d
Cleared Dec 15, 2004
GENTLEWAVES LED PHOTOMODULATION DEVICE
K031425 · GEX
Light Bioscience, LLC
General & Plastic Surgery · 590d
Cleared Dec 15, 2004
NEWPORT C250 AIR COMPRESSOR MODEL C250
K041406 · BTI
Newport Medical Instruments
Anesthesiology · 203d
Cleared Dec 15, 2004
ANEMIAPRO SELF-SCREENER
K042379 · KHG
Biosafe Laboratories, Inc.
Hematology · 105d
Cleared Dec 15, 2004
DIRECT DIGITIZER, REGIUS MODEL 190
K042386 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 104d
Cleared Dec 15, 2004
SCENIUM
K042863 · KPS
Siemens Molecular Imaging, Ltd.
Radiology · 58d
Cleared Dec 15, 2004
SOMATOM CARE CONTRAST CT
K043087 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 37d
Cleared Dec 15, 2004
GERBER DOUBLE ELECTRIC BREAST PUMP
K043098 · HGX
Gerber Products Co.
Obstetrics & Gynecology · 36d
Cleared Dec 15, 2004
TORPICALGIN
K043131 · ELW
Zhermack S.P.A.
Dental · 33d
Cleared Dec 15, 2004
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS,...
K043153 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Dec 15, 2004
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · LLZ
Vital Images, Inc.
Radiology · 12d
Cleared Dec 15, 2004
MISTAR, MODEL V3.2
K043350 · LLZ
Apollo Medical Imaging Technology...
Radiology · 9d
Cleared Dec 14, 2004
PLLA CANNULATED INTERFERENCE SCREW
K032830 · HWC
Advanced Biomaterials
Orthopedic · 460d
Cleared Dec 14, 2004
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON...
K040671 · EJI
Anthogyr
Dental · 274d
Cleared Dec 14, 2004
ULTRALIGHT II ND:YAG LASER SYSTEM
K041011 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 238d
Cleared Dec 14, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
K042481 · JXG
Sophysa SA
Neurology · 92d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552 · HWC
Biomet, Inc.
Orthopedic · 85d
Cleared Dec 14, 2004
OPUS MINIMAGNUM ANCHOR WITH INSERTER
K042584 · HWC
Opus Medical, Inc.
Orthopedic · 83d
Cleared Dec 14, 2004
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
K042592 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 82d
Cleared Dec 14, 2004
BIOPLUS
K042636 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 78d
Cleared Dec 14, 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · GEX
Nidek, Inc.
General & Plastic Surgery · 69d