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
56737–56760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2008
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
K080556 · EBG
Merz Dental GmbH
Dental · 64d
Cleared May 02, 2008
STD MED PRIMO PORT POLY
K080645 · LJT
Std Med, Inc.
General Hospital · 57d
Cleared May 02, 2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K080646 · KWQ
Biomet Spine
Orthopedic · 57d
Cleared May 02, 2008
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
K080887 · LKM
Sysmex America, Inc.
Pathology · 32d
Cleared May 02, 2008
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING...
K080911 · GKA
Bio-Rad Laboratories Inc., Clinical...
Hematology · 30d
Cleared May 02, 2008
DSS STABILIZATION SYSTEM
K080963 · NQP
Paradigm Spine
Orthopedic · 28d
Cleared May 02, 2008
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS...
K080967 · HCG
Cordis Neurovascular, Inc.
Neurology · 28d
Cleared May 02, 2008
EAR THERMOMETER, MODELS ST66 AND ST67
K080981 · FLL
Mesure Technology Co., Ltd.
General Hospital · 25d
Cleared May 02, 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · FMF
Icu Medical, Inc.
General Hospital · 25d
Cleared May 02, 2008
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
K081004 · FDF
Stryker GI
Gastroenterology & Urology · 24d
Cleared May 02, 2008
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
K081005 · NHA
Institut Straumann AG
Dental · 24d
Cleared May 02, 2008
MODIFICATION TO PROFLU+ ASSAY
K081030 · OCC
Prodesse, Inc.
Microbiology · 21d
Cleared May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
K081079 · JAQ
Senorx, Inc.
Radiology · 16d
Cleared May 02, 2008
AESKULISA ANA HEP-2, REF 30-7115US
K081104 · LKJ
Aesku Diagnostics
Immunology · 14d
Cleared May 02, 2008
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
K081109 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 14d
Cleared May 02, 2008
NORAS MR-BI320-PA 1.5T
K081118 · MOS
Noras Mri Products GmbH
Radiology · 11d
Cleared May 02, 2008
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
K081143 · DYW
Biomers Product, LLC
Dental · 10d
Cleared May 02, 2008
MOBLVAC W.C.
K081185 · BTA
Ohio Medical Corporation
General & Plastic Surgery · 7d
Cleared May 01, 2008
SUPRASORB A +AG
K071442 · FRO
Specialty Fibres and Materials, Ltd.
General & Plastic Surgery · 344d
Cleared May 01, 2008
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE,...
K071983 · MAX
Aesculap Implant Systems, Inc.
Orthopedic · 287d
Cleared May 01, 2008
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K073532 · GXY
Technomed Europe
Neurology · 136d
Cleared May 01, 2008
PATHWAY
K080281 · MAX
Custom Spine, Inc.
Orthopedic · 87d
Cleared May 01, 2008
PROCHEM INDICATOR TAPE
K080307 · JOJ
Raven Laboratories
General Hospital · 86d
Cleared May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568 · MQP
Depuy Spine, Inc.
Orthopedic · 62d