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
75025–75048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · MRR
Hemagen Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 2002
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K022818 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 22d
Cleared Sep 17, 2002
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · JTW
Gen-Probe, Inc.
Microbiology · 53d
Cleared Sep 17, 2002
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
K022878 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 18d
Cleared Sep 17, 2002
M2376A DEVICELINK SYSTEM
K022920 · MWI
Philips Medical Systems
Cardiovascular · 13d
Cleared Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
K022991 · JJY
Bio-Rad
Immunology · 8d
Cleared Sep 16, 2002
SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018
K020462 · ILY
Rolor Electronics Corp.
Physical Medicine · 216d
Cleared Sep 16, 2002
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
K021983 · MMK
Ultimed, Inc.
General Hospital · 90d
Cleared Sep 16, 2002
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT...
K022343 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 59d
Cleared Sep 16, 2002
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K022600 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 42d
Cleared Sep 16, 2002
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
K022639 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 39d
Cleared Sep 16, 2002
POWDERED SYNTHETIC VINYL EXAM GLOVES
K022702 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 33d
Cleared Sep 16, 2002
MODIFICATION TO PLAYTEX TAMPONS #24002
K022882 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 17d
Cleared Sep 13, 2002
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
K014141 · DXN
Digibio Technology Corp.
Cardiovascular · 270d
Cleared Sep 13, 2002
AB BELT
K020427 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
AB BELT PRO
K020429 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
RSV OIA
K021172 · GOG
Thermo Biostar, Inc.
Microbiology · 154d
Cleared Sep 13, 2002
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · IMI
Rich-Mar Corp.
Physical Medicine · 128d
Cleared Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
K021687 · GQG
Binax, Inc.
Microbiology · 114d
Cleared Sep 13, 2002
LASERSYSTEM BEAUTYSTAR 532
K021975 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Sep 13, 2002
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
K021989 · LFL
Integra Neurosciences
General & Plastic Surgery · 87d
Cleared Sep 13, 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · DYB
Micro Therapeutics, Inc.
Cardiovascular · 86d
Cleared Sep 13, 2002
CONDUCTIVE GEL
K022006 · GYB
The Dezac Group
Neurology · 86d
Cleared Sep 13, 2002
URETERAL ACCESS SHEATH SET (UASS)
K022135 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 74d