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

Filters: Cleared only ×
176,076 results
68137–68160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2004
HAUSTED POWERTRAN SERIES STRETCHER
K041924 · INK
STERIS Corporation
Physical Medicine · 55d
Cleared Sep 09, 2004
VISULAS YAG III
K042139 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 31d
Cleared Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · LCX
ACON Laboratories, Inc.
Chemistry · 31d
Cleared Sep 09, 2004
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K042213 · LYZ
Shandong Perfect Plastic Co., Ltd.
General Hospital · 24d
Cleared Sep 09, 2004
PACSPARTNER
K042311 · LLZ
Medical Standard Co., Ltd.
Radiology · 14d
Cleared Sep 09, 2004
INTEGRADWEB MPR/MIP
K042313 · LLZ
Dynamic Imaging, Inc.
Radiology · 14d
Cleared Sep 08, 2004
X-SIZER CATHETER SYSTEM
K021096 · MCW
Ev3 Corporation
Cardiovascular · 888d
Cleared Sep 08, 2004
VACUUM ASSISTED CORE BIOPSY DEVICE
K034021 · KNW
Suros Surgical Systems, Inc.
Gastroenterology & Urology · 259d
Cleared Sep 08, 2004
VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE &...
K040662 · ILY
Chattanooga Group
Physical Medicine · 180d
Cleared Sep 08, 2004
ECHOSAMPLER
K041237 · HFF
Gynetics Medical Products NV
Obstetrics & Gynecology · 120d
Cleared Sep 08, 2004
SYNERGY ULTIMATE
K041346 · ITI
Pride Mobility Products Corp.
Physical Medicine · 111d
Cleared Sep 08, 2004
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
K041516 · FLL
Vega Technologies, Inc.
General Hospital · 96d
Cleared Sep 08, 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
K041566 · LFL
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 90d
Cleared Sep 08, 2004
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
K041611 · GXR
Synthes (Usa)
Neurology · 85d
Cleared Sep 08, 2004
STALIF TT
K041617 · MQP
Surgicraft , Ltd.
Orthopedic · 85d
Cleared Sep 08, 2004
LTD POLYAXIAL FIXATION SYSTEM
K041625 · KWQ
Us Spinal Technologies, LLC
Orthopedic · 85d
Cleared Sep 08, 2004
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
K041655 · DZE
Cowellmedi Co., Ltd.
Dental · 82d
Cleared Sep 08, 2004
TRIMEDYNE HOLMIUM LASER SYSTEMS
K041660 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 82d
Cleared Sep 08, 2004
HOFFMANN II FOOT RING
K041706 · KTT
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
NUMELOCK II SYSTEM
K041709 · KTT
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749 · HWC
Scandius Biomedical, Inc.
Orthopedic · 71d
Cleared Sep 08, 2004
CALCAMEA PLATE
K041786 · HRS
New Deal, S.A.
Orthopedic · 69d
Cleared Sep 08, 2004
EXPEDIUM MIS SPINE SYSTEM
K041801 · NKB
Depuy Spine, Inc.
Orthopedic · 68d
Cleared Sep 08, 2004
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
K041860 · HRS
Synthes (Usa)
Orthopedic · 61d