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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142777–142800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1986
BREMI BEAUTY BRONZE
K863555 · FTC
Handelsonderneming Bremi B.V.
General & Plastic Surgery · 20d
Cleared Oct 02, 1986
URESIL RADIOPAQUE SILICONE BANDS
K863563
Uresil Corp.
General & Plastic Surgery · 20d
Cleared Oct 02, 1986
VIDEO CAMERA SYSTEM
K863598 · FWF
American Edwards Laboratories
General & Plastic Surgery · 17d
Cleared Oct 02, 1986
MICRO SURGICAL DRILL SYSTEM
K863627
Acumed Instruments Corp.
General & Plastic Surgery · 15d
Cleared Oct 02, 1986
GENTEEL
K863676 · ELC
Luben Dental Co., Inc.
Dental · 13d
Cleared Oct 02, 1986
MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K863697 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 10d
Cleared Oct 01, 1986
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · DSP
Kontron Instruments, Inc.
Cardiovascular · 223d
Cleared Oct 01, 1986
TRACKER INFUSION CATHETER
K862117 · DQY
Target Therapeutics
Cardiovascular · 120d
Cleared Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · GQI
Labsystems, Inc.
Microbiology · 77d
Cleared Oct 01, 1986
STOCKERT-SHILEY CAPS TIMER MODULE
K862973 · DTQ
Shiley, Inc.
Cardiovascular · 56d
Cleared Oct 01, 1986
EUROFLEX F-IV, ISOFLEX III
K863007
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
MINILAX SET
K863012
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
ISOLAX PEDAL SET
K863013
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
ISOPRAT F-III SET/ISOLAX CHAIR
K863014
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT
K863015
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
DENTATUS L SET
K863016 · KLC
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
CM-II, CM-I WATER UNIT
K863021 · EIA
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
IMMUNO BIOTECH MUGWART ALLERGEN DISC
K863123 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Oct 01, 1986
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
K863425 · CDW
American Research Products Co.
Chemistry · 27d
Cleared Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487 · DBF
Bio-Rad
Immunology · 22d
Cleared Sep 30, 1986
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
K854533
Madsen Electronics (Canada) , Ltd.
Neurology · 321d
Cleared Sep 30, 1986
COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
K862814 · LQP
Institute Virion , Ltd.
Microbiology · 68d
Cleared Sep 30, 1986
SHARPOINT STAINLESS STEEL SUTURE
K863034 · GAO
Chathamborough Research Group, Inc.
General & Plastic Surgery · 50d
Cleared Sep 30, 1986
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · LQL
American Micro Scan
Microbiology · 49d