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
67201–67224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2004
CONSERVE PLUS HA ACETABULAR SHELLS
K042530 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Dec 17, 2004
RADIANCE PORCELAIN
K042638 · EIH
Aurident, Inc.
Dental · 81d
Cleared Dec 17, 2004
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · FXX
Safety-Med Products, Inc.
General Hospital · 80d
Cleared Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · DHA
Nichols Institute Diagnostics
Chemistry · 79d
Cleared Dec 17, 2004
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · KRH
St. Jude Medical, Inc.
Cardiovascular · 77d
Cleared Dec 17, 2004
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
K042783 · HBE
The Anspach Effort, Inc.
Neurology · 72d
Cleared Dec 17, 2004
IS 40 MICROMOTOR
K042787 · EFB
Satelec
Dental · 72d
Cleared Dec 17, 2004
SYSTEMP.CEM
K042847 · EMA
Ivoclar Vivadent, Inc.
Dental · 63d
Cleared Dec 17, 2004
FLEXITIME XTREME
K042878 · ELW
Heraeus Kulzer, Inc.
Dental · 60d
Cleared Dec 17, 2004
MD-6W WIRELESS CRITICAL DATA VIEWER
K042923 · GCJ
The Microoptical Corporation
General & Plastic Surgery · 56d
Cleared Dec 17, 2004
NOUVAG AG - VACUSON 40 AND VACUSON 60
K042943 · BTA
NOUVAG AG
General & Plastic Surgery · 53d
Cleared Dec 17, 2004
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · KWS
Tornier
Orthopedic · 39d
Cleared Dec 17, 2004
AMELOGEN PLUS
K043119 · EBF
Ultradent Products, Inc.
Dental · 37d
Cleared Dec 17, 2004
CLEAFIL DC CORE AUTOMIX
K043177 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Dec 17, 2004
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K043181 · KWQ
Vertebron, Inc.
Orthopedic · 30d
Cleared Dec 17, 2004
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
K043293 · KPS
Acrorad Co., Ltd.
Radiology · 18d
Cleared Dec 17, 2004
CRANEX D
K043307 · EHD
Soredex Palodex Group OY
Radiology · 16d
Cleared Dec 17, 2004
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
K043319 · GEX
Novalis Medical, LLC
General & Plastic Surgery · 15d
Cleared Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
K043320 · JJX
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Dec 17, 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS,...
K043355 · KWP
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Dec 17, 2004
PERMACOL SURGICAL IMPLANT
K043366 · FTL
Tissue Science Laboratories, Plc
General & Plastic Surgery · 9d
Cleared Dec 16, 2004
VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5,...
K033266 · DQK
Medical Imaging Applications, LLC
Cardiovascular · 434d
Cleared Dec 16, 2004
OPUSDUO
K040270 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 315d
Cleared Dec 16, 2004
COLD LIGHT
K041679 · ILY
Onyx Medical, Inc.
Physical Medicine · 178d