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
54601–54624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2009
ATRIUM PROLITE S MESH
K082748 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 117d
Cleared Jan 14, 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025 · HRS
Synthes (Usa)
Orthopedic · 96d
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Jan 14, 2009
MODIFICATION TO URESTA PESSARY
K083769 · HHW
Eastmed, Inc.
Obstetrics & Gynecology · 27d
Cleared Jan 14, 2009
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
K083916 · LLZ
Nec Display Solutions , Ltd.
Radiology · 15d
Cleared CT Jan 13, 2009
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF...
K072971 · OBO
Topcon Medical Systems, Inc.
Ophthalmic · 449d
Cleared Jan 13, 2009
RESPIFIT S, MODEL RS-LR1001004
K080299 · BWF
Eumedics Medizintechnik Und Marketing...
Anesthesiology · 343d
Cleared Jan 13, 2009
TRAUSON INTRAMEDULLARY NAIL
K081230 · HSB
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 258d
Cleared Jan 13, 2009
PRUMYX CREAM
K082089 · FRO
Prugen, Inc.
General & Plastic Surgery · 173d
Cleared Jan 13, 2009
DIAZYME LP(A) ASSAY
K082488 · DFC
General Atomics
Chemistry · 138d
Cleared Jan 13, 2009
VPAP AUTO WITH HUMIDAIRE 3I
K082605 · BZD
Resmed, Ltd.
Anesthesiology · 127d
Cleared Jan 13, 2009
MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
K083082 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 89d
Cleared Jan 13, 2009
NEWPORT SPINAL SYSTEM
K083089 · NKB
Seaspine, Inc.
Orthopedic · 89d
Cleared Jan 13, 2009
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · FET
Olympus Medical Systems Corporation
Gastroenterology & Urology · 81d
Cleared Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Jan 13, 2009
PHENIX CERVICAL INTERBODY DEVICE
K083167 · ODP
Spinal Devices, LLC
Orthopedic · 78d
Cleared Jan 13, 2009
INTRATEMP SOLUTION WARMER
K083417 · LHC
C Change Surgical, LLC
General Hospital · 56d
Cleared Jan 13, 2009
CAPSURE PS SYSTEM
K083743 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jan 13, 2009
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
K083814 · PDU
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 22d
Cleared Jan 13, 2009
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)
K083837 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 21d
Cleared Jan 13, 2009
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
K083877 · ITX
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jan 13, 2009
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
K083907 · LLZ
Nec Display Solutions , Ltd.
Radiology · 14d
Cleared Jan 12, 2009
ASCENSION SILICONE PIP
K082231 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 158d
Cleared Jan 12, 2009
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
K082622 · NUV
Alma Lasers , Ltd.
General & Plastic Surgery · 125d