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
32089–32112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716 · HRS
Gpc Medical, Ltd.
Orthopedic · 145d
Cleared May 17, 2016
Third Eye Panoramic Auxiliary Endoscopy System - Resposable
K160356 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared May 17, 2016
PicoSure Workstation
K160480 · GEX
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared May 17, 2016
Escalade Legend Acetabular Shell
K161080 · LPH
Ortho Development Corporation
Orthopedic · 29d
Cleared May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone...
K161082 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared May 16, 2016
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
K152754 · PHX
Biomet Manufacturing Corp
Orthopedic · 235d
Cleared May 16, 2016
Aesculap OrthoPilot Next Generation
K153396 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 174d
Cleared May 16, 2016
Trak Male Fertility Testing System
K153683 · POV
Sandstone Diagnostics, Inc.
Hematology · 146d
Cleared May 16, 2016
Lumipulse G ROMA
K160090 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 122d
Cleared May 16, 2016
MagPro R20
K160280 · GWF
Tonica Elektronik A/S
Neurology · 104d
Cleared May 13, 2016
Bindex BI-100
K152020 · MUA
Bone Index Finland , Ltd.
Radiology · 297d
Cleared May 13, 2016
Astral 100/150
K152068 · CBK
Resmed, Ltd.
Anesthesiology · 294d
Cleared May 13, 2016
SeraQuest HSV Type 2 Specific IgG
K152353 · MYF
Quest International, Inc.
Microbiology · 267d
Cleared May 13, 2016
UltraCor Twirl Breast Tissue Marker
K152510 · NEU
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 254d
Cleared May 13, 2016
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045 · BXN
Easy Med Instrument Co., Ltd.
Anesthesiology · 207d
Cleared May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix...
K153236 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 186d
Cleared May 13, 2016
DD medical polymers
K153490 · EBG
Dental Direkt GmbH
Dental · 161d
Cleared May 13, 2016
AirFit F20
K153563 · BZD
Resmed, Ltd.
Anesthesiology · 151d
Cleared May 13, 2016
ArcCHECK-MR
K160057 · IYE
Sun Nuclear Corporation
Radiology · 122d
Cleared May 13, 2016
ALTA Anterior Cervical Interbody Spacer
K160154 · ODP
Astura Medical
Orthopedic · 114d
Cleared May 13, 2016
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K160240 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 102d
Cleared May 13, 2016
LT-300 HD
K160380 · HEX
Lutech Industries, Inc.
Obstetrics & Gynecology · 93d
Cleared May 13, 2016
Oasis Lacrimal Intubation Set
K160710 · OKS
Anodyne
Ophthalmic · 59d
Cleared May 13, 2016
Diagnostic Imaging Color LCD Monitor
K161057 · PGY
Nec Display Solutions , Ltd.
Radiology · 29d