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
69073–69096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2004
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
K041337 · IOR
Pro Walker, Inc.
Physical Medicine · 9d
Cleared May 28, 2004
VENOJECT LUER ADAPTER
K041358 · JKA
Terumo Europe N.V.
Chemistry · 7d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · LZG
Smiths Medical MD, Inc.
General Hospital · 358d
Cleared May 27, 2004
DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
K032397 · GEX
Norseld Pty., Ltd.
General & Plastic Surgery · 297d
Cleared May 27, 2004
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL
K032897 · LLH
Ivd Research, Inc.
Microbiology · 253d
Cleared May 27, 2004
SPINAL CONCEPTS INC. CODA
K033663 · MQP
Spinal Concepts, Inc.
Orthopedic · 188d
Cleared May 27, 2004
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
K033704 · JXG
Vygon Us, LLC
Neurology · 184d
Cleared May 27, 2004
COMPPAC 200HD
K040090 · BTL
Pneupac , Ltd.
Anesthesiology · 132d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411 · LAS
Microgenics Corp.
Toxicology · 99d
Cleared May 27, 2004
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND...
K040512 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared May 27, 2004
MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
K040581 · DQA
Vitel Net
Anesthesiology · 84d
Cleared May 27, 2004
PORTA REFLEX
K040672 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 73d
Cleared May 27, 2004
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K040914 · LRX
Exero Products, Inc.
Ophthalmic · 49d
Cleared May 27, 2004
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · KRR
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL...
K041227 · JJY
Roche Diagnostics Corp.
Chemistry · 17d
Cleared May 27, 2004
CARDIQ ANALYSIS III
K041267 · JAK
General Electric Medical Systems
Radiology · 15d
Cleared May 27, 2004
CT COLONOGRAPHY II
K041270 · LLZ
General Electric Medical Systems
Radiology · 15d
Cleared May 27, 2004
PROCERA ABUTMENT OCTAGON
K041275 · NHA
Nobel Biocare Uas, Inc.
Dental · 15d
Cleared May 26, 2004
ZARGIS ACOUSTIC CARDIOSCAN
K031517 · DQD
Zargis Medical Corp.
Cardiovascular · 377d
Cleared May 26, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
K040246 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 113d
Cleared May 26, 2004
IMPAX CLIENT EMBRACE
K040555 · LLZ
Agfa Corp.
Radiology · 85d
Cleared May 26, 2004
MODIFICATION TO NXSTAGE SYSTEM ONE
K040696 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 70d
Cleared May 26, 2004
PHOTOSILK PULSED LIGHT SYSTEM
K041095 · GEX
Cynosure, Inc.
General & Plastic Surgery · 29d
Cleared May 26, 2004
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
K041236 · NHA
Nobel Biocare AB
Dental · 15d