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
68401–68424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2004
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
K042022 · DXH
Datrix, Inc. Dba of Jon Barron, Inc.
Cardiovascular · 15d
Cleared Aug 11, 2004
MERCI RETRIEVER, MODELS 90065, 90066
K033736 · NRY
Concentric Medical, Inc.
Neurology · 257d
Cleared Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710 · FPA
Icu Medical, Inc.
General Hospital · 146d
Cleared Aug 11, 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · DQY
Concentric Medical, Inc.
Cardiovascular · 141d
Cleared Aug 11, 2004
EZ SMART
K040848 · NBW
Vip International Wholesalers, Corp.
Chemistry · 132d
Cleared Aug 11, 2004
PEDIATRIC REFERENCE DATABASE
K041266 · KGI
Hologic, Inc.
Radiology · 91d
Cleared Aug 11, 2004
ALCOMATE, MODEL CA2000
K041334 · DJZ
Khn Solutions, LLC
Toxicology · 84d
Cleared Aug 11, 2004
ADVANCED D-DIMER ASSAY
K041438 · DAP
Dade Behring, Inc.
Hematology · 71d
Cleared Aug 11, 2004
TERUMO CIRCUIT CONNECTORS
K041697 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 50d
Cleared Aug 11, 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · JHI
Immunostics Inc.,
Chemistry · 47d
Cleared Aug 11, 2004
NEW BRID
K041780 · OWB
Medical Imaging Solutions, Inc.
Radiology · 41d
Cleared Aug 11, 2004
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
K041948 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 22d
Cleared Aug 11, 2004
MARK III PHASED ARRAY SHOULDER COIL
K042009 · MOS
Usa Instruments, Inc.
Radiology · 16d
Cleared Aug 10, 2004
HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM
K040651 · DXN
Hommed, LLC
Cardiovascular · 152d
Cleared Aug 10, 2004
BINAXNOW INFLUENZA A & B TEST
K041049 · PSZ
Binax, Inc.
Microbiology · 110d
Cleared Aug 10, 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
K041231 · NOP
Panbio Limited
Microbiology · 92d
Cleared Aug 10, 2004
ELEKTA OY
K041264 · OLX
Elekta Neuromag OY
Neurology · 90d
Cleared Aug 10, 2004
CURVED PEEK TETRIS SPINAL IMPLANT
K041888 · MQP
Signus Medizintechnik GmbH
Orthopedic · 29d
Cleared Aug 09, 2004
STIMULEN COLLAGEN
K030774 · KGN
Southwest Technologies, Inc.
General & Plastic Surgery · 517d
Cleared Aug 09, 2004
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
K032954 · IPF
Danmeter A/S
Physical Medicine · 322d
Cleared Aug 09, 2004
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
K033135 · KNS
Stryker Endoscopy
Gastroenterology & Urology · 314d
Cleared Aug 09, 2004
PERFORMANCE WATER TREATMENT SYSTEM
K033648 · FIP
Performance Water Systems, LLC
Gastroenterology & Urology · 263d
Cleared Aug 09, 2004
DELTA T
K041076 · CAD
Penlon , Ltd.
Anesthesiology · 105d
Cleared Aug 09, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · MQP
Medtronic Sofamor Danek
Orthopedic · 94d