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
54337–54360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2009
INFINITI VISION SYSTEM WITH OZIL IP
K082845 · HQC
Alcon Research, Ltd.
Ophthalmic · 139d
Cleared Feb 12, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083047 · LYZ
Zibo Wanci Plastic & Rubber Co., Ltd.
General Hospital · 121d
Cleared Feb 12, 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K083180 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 107d
Cleared Feb 12, 2009
TORNIER, INC., INSITE SUTURE ANCHORS
K083268 · MAI
Tornier, Inc.
Orthopedic · 99d
Cleared Feb 12, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM,...
K083500 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 79d
Cleared Feb 12, 2009
LIQUIBAND ULTIMA, MODEL LB0004
K083531 · MPN
Medlogic Global , Ltd.
General & Plastic Surgery · 76d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655 · JJX
Roche Diagnostics
Microbiology · 64d
Cleared Feb 12, 2009
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K083742 · LYC
Collagen Matrix, Inc.
Dental · 58d
Cleared Feb 12, 2009
LDR SPINE ROI-C IMPLANT
K083857 · MQP
Ldr Spine USA
Orthopedic · 50d
Cleared Feb 12, 2009
MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
K090085 · NRY
Concentric Medical, Inc.
Neurology · 30d
Cleared Feb 12, 2009
BELMONT HYPERTHERMIA PUMP
K090089 · LGZ
Belmont Instrument Corp.
General Hospital · 29d
Cleared Feb 12, 2009
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION...
K090102 · MPB
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 11, 2009
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
K080436 · DIO
Quantrx Biomedical Corporation
Toxicology · 358d
Cleared Feb 11, 2009
KERATEC WOUND DRESSINGS
K080949 · FRO
Keratec Limited
General & Plastic Surgery · 314d
Cleared Feb 11, 2009
NEO MAPCATH SENSOR STYLET
K083121 · OMF
Corpak Medsystems
General Hospital · 112d
Cleared Feb 11, 2009
NEOSS PROACTIVE IMPLANT
K083561 · DZE
Neoss, Ltd.
Dental · 71d
Cleared Feb 11, 2009
AXXENT SURFACE APPLICATOR, MODEL 710257
K083734 · JAD
Xoft, Inc.
Radiology · 57d
Cleared Feb 11, 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA,...
K083828 · MXC
Transoma
Cardiovascular · 50d
Cleared Feb 11, 2009
CD4 COUNT
K083926 · GGL
Streck
Hematology · 42d
Cleared Feb 11, 2009
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
K090103 · MAY
Biomet, Inc.
Orthopedic · 27d
Cleared Feb 11, 2009
WATERLASE MD
K090181 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 16d
Cleared Feb 11, 2009
COLON VIEW, MODEL CSCV-001A
K090220 · JAK
Toshibamedical Systems Corporation
Radiology · 13d
Cleared Feb 10, 2009
PRO QR ADVANCED FORMULA POWDER
K080210 · QSY
Biolife, LLC
General & Plastic Surgery · 379d
Cleared Feb 10, 2009
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
K081560 · DWF
Vascutek, Ltd.
Cardiovascular · 252d