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
67633–67656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2004
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
K042434 · DZI
NOUVAG AG
Dental · 56d
Cleared Nov 03, 2004
BEST BREAST BRACHYTHERAPY APPLICATOR
K042586 · JAQ
Best Medical International, Inc.
Radiology · 42d
Cleared Nov 03, 2004
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
K042642 · MHX
Ge Medical Systems Information...
Cardiovascular · 37d
Cleared Nov 03, 2004
HI-ART SYSTEM
K042739 · MUJ
Tomotherapy Incorporated
Radiology · 30d
Cleared Nov 03, 2004
GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6...
K042844 · MOS
Ge Medical Systems, Inc.
Radiology · 19d
Cleared Nov 03, 2004
JETSTREAM WORKSPACE
K042880 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 03, 2004
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
K042948 · LNH
Wandong Medical
Radiology · 8d
Cleared Nov 02, 2004
SHUNTCHECK (PROMETHEUS 1)
K040021 · JXG
Samuel Neff M.D.
Neurology · 301d
Cleared Nov 02, 2004
3M TEGADERM SILVER
K040890 · FRO
3M Company
General & Plastic Surgery · 223d
Cleared Nov 02, 2004
NEOPLANT IMPLANT SYSTEM
K042339 · DZE
Neobiotech Co., Ltd.
Dental · 64d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · JJW
Bio-Rad Laboratories, Inc.
Chemistry · 54d
Cleared Nov 02, 2004
ADEPT ULTRALITE 532 LASER
K042496 · GEX
Adept Medical Concepts
General & Plastic Surgery · 49d
Cleared Nov 02, 2004
CUFFPATCH
K042809 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 21d
Cleared Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
K042837 · JJX
Bio-Rad
Chemistry · 19d
Cleared Nov 02, 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
K042866 · IZL
Ge Healthcare Technologies
Radiology · 15d
Cleared Nov 02, 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · LLZ
Philips Medical Systems North...
Radiology · 15d
Cleared Nov 01, 2004
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
K040301 · MPB
Gambro Renal Products
Gastroenterology & Urology · 266d
Cleared Nov 01, 2004
TRIFUSION, MODEL 0609190/0659350
K041088 · LJS
C.R. Bard, Inc.
General Hospital · 189d
Cleared Nov 01, 2004
INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
K042069 · GCJ
Acmi Corporation
General & Plastic Surgery · 91d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · HRY
Biomet, Inc.
Orthopedic · 90d
Cleared Nov 01, 2004
VERSATILE 1 WOUND VACUUM SYSTEM
K042134 · OMP
Blue Sky Medical Group Incorporated
General & Plastic Surgery · 84d
Cleared Nov 01, 2004
SAVEDENT BLUE
K042196 · EBZ
Denfotex Light Systems, Ltd.
Dental · 80d
Cleared Nov 01, 2004
FUTURABOND NR
K042670 · KLE
Voco GmbH
Dental · 33d
Cleared Oct 29, 2004
MENTOR GENESIS PENILE PROSTHESIS
K040959 · FAE
Mentor Corp.
Gastroenterology & Urology · 199d