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
75169–75192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
K022088 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K022092 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 30, 2002
SLEEPFLO, MODEL 101501
K020607 · MNR
Biomec, Inc.
Anesthesiology · 186d
Cleared Aug 30, 2002
VERACAM
K021083 · EIA
Lumalite, Inc.
Dental · 149d
Cleared Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
K021162 · JPA
Sigma Diagnostics, Inc.
Hematology · 141d
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265 · CAH
Datex-Ohmeda
General Hospital · 130d
Cleared Aug 30, 2002
ENDOSSEOUS IMPLANT
K021355 · DZE
Branemark Integration AB
Dental · 123d
Cleared Aug 30, 2002
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
K021493 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 113d
Cleared Aug 30, 2002
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE...
K021781 · CGA
Chay Medical, LLC
Chemistry · 92d
Cleared Aug 30, 2002
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
K021837 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 28d
Cleared Aug 30, 2002
PVP (POLYVINYLPYRROLIDONE)
K022590 · MQL
Intl., Inc.
Obstetrics & Gynecology · 25d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591 · JJY
Randox Laboratories, Ltd.
Chemistry · 25d
Cleared Aug 30, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K022795 · NHA
BioHorizons Implant Systems, Inc.
Dental · 7d
Cleared Aug 29, 2002
WS-501 HEAT LAMP
K013197 · ILY
Lhasa Medical, Inc.
Physical Medicine · 338d
Cleared Aug 29, 2002
ALPHACOR
K013756 · HQM
Argus Biomedical Pty, Ltd.
Ophthalmic · 289d
Cleared Aug 29, 2002
ABR-2000
K020360 · GZO
Meridian Co., Ltd.
Neurology · 206d
Cleared Aug 29, 2002
NONCOR INFUSION SETS
K021080 · FPA
Cardio Med Supplies, Inc.
General Hospital · 148d
Cleared Aug 29, 2002
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
K021807 · OLV
Grass Instrument Co.
Neurology · 87d