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
69697–69720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2004
SYDNEY IVF PVP
K031304 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 334d
Cleared Mar 23, 2004
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
K033109 · MQP
Scient'X
Orthopedic · 175d
Cleared Mar 23, 2004
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
K033149 · KPL
Ultimate Concepts, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 23, 2004
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
K034045 · MQN
Oral Osteodistraction, L.P.
Dental · 85d
Cleared Mar 23, 2004
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K040064 · KTT
Newmedical Technology, Inc.
Orthopedic · 70d
Cleared Mar 23, 2004
BONE-LOK HP WASHER
K040250 · HTN
Triage Medical, Inc.
Orthopedic · 50d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · KTT
Synthes (Usa)
Orthopedic · 48d
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · MQP
Globus Medical, Inc.
Orthopedic · 46d
Cleared Mar 23, 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 43d
Cleared Mar 23, 2004
GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE,...
K040448 · LYY
Rosner-Mautby Meditrade(Thailand) , Ltd.
General Hospital · 32d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 23, 2004
TERUMO SURGUARD2 SAFETY NEEDLE
K040531 · FMI
Terumo Medical Corp.
General Hospital · 22d
Cleared Mar 23, 2004
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
K040532 · LYZ
Zi BO Hong Wang Plastic & Rubber...
General Hospital · 22d
Cleared Mar 23, 2004
ROBERTSITE VIAL ADAPTER, MODEL 245700021
K040634 · LHI
Halkey-Roberts Corp.
General Hospital · 13d
Cleared Mar 23, 2004
INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
K040691 · EIA
Win-Us Technology Co., Ltd.
Dental · 6d
Cleared Mar 22, 2004
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
K031487 · DXN
Nonin Medical, Inc.
Cardiovascular · 315d
Cleared Mar 22, 2004
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
K032292 · FOZ
Bioteque Corp.
General Hospital · 242d
Cleared Mar 22, 2004
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
K033000 · BYJ
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 179d
Cleared Mar 22, 2004
BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
K033454 · JZO
Brahms Diagnostica, LLC
Immunology · 144d
Cleared Mar 22, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 119d
Cleared Mar 22, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
K033977 · JZO
Zeus Scientific, Inc.
Immunology · 90d
Cleared Mar 22, 2004
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B
K034050 · DTK
Cordis Corporation
Cardiovascular · 83d
Cleared Mar 22, 2004
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
K040002 · DXN
Microlife Intellectual Property Gmb
Cardiovascular · 80d
Cleared Mar 22, 2004
APM BLOOD PRESSURE MONITOR, MODEL BP108A
K040159 · DXN
Asia Pacific Microsystems, Inc.
Cardiovascular · 59d