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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
138913–138936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1987
DAHLBERG MODEL GH BODY AID
K873169 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 16, 1987
HEARING AID (ALL-IN-THE-EAR)
K873189 · ESD
Sight-N-Sound & Co.
Ear, Nose, Throat · 34d
Cleared Sep 16, 1987
MERIFLUOR(TM)-GIARDIA
K873299 · GWD
Meridian Diagnostics, Inc.
Microbiology · 29d
Cleared Sep 16, 1987
120Z(TENS)
K873484 · GZJ
Oms Medico, Inc.
Neurology · 16d
Cleared Sep 16, 1987
LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM
K873507 · JDR
Link America, Inc.
Orthopedic · 16d
Cleared Sep 15, 1987
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271 · DRM
Huntleigh Technology, Inc.
Cardiovascular · 168d
Cleared Sep 15, 1987
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · BYE
Puritan Bennett Corp.
Anesthesiology · 139d
Cleared Sep 15, 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 127d
Cleared Sep 15, 1987
MR420 TRANSPORT HUMIDIFIER
K872139 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 105d
Cleared Sep 15, 1987
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
K872230 · DBT
Intermedics, Inc.
Hematology · 98d
Cleared Sep 15, 1987
COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470
K872355 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 89d
Cleared Sep 15, 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · KDI
Minntech Corp.
Gastroenterology & Urology · 84d
Cleared Sep 15, 1987
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · DXG
American Edwards Laboratories
Cardiovascular · 81d
Cleared Sep 15, 1987
TRACH CARE CATHETER
K872621 · BSY
Ballard Medical Products
Anesthesiology · 71d
Cleared Sep 15, 1987
OXIMETRY MODULE
K872626 · DQA
Marquette Electronics, Inc.
Anesthesiology · 71d
Cleared Sep 15, 1987
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741
K872629 · DXN
A&D Engineering, Inc.
Cardiovascular · 71d
Cleared Sep 15, 1987
SHEATH/DILATORS
K872724 · DRE
Med-West, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · DTB
Ela Medical, Inc.
Cardiovascular · 69d
Cleared Sep 15, 1987
PERFUSION CATHETER
K872790 · DQT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 63d
Cleared Sep 15, 1987
POLYURETHANE CATHETER FOR THE INFUSE-A-PORT
K872898 · LJT
Shiley Infusaid, Inc.
General Hospital · 54d
Cleared Sep 15, 1987
MEGABED 1000
K872925 · FNL
Surgi-Med, Inc.
General Hospital · 50d
Cleared Sep 15, 1987
MOSS(R) MARK IV NASAL TUBES CAT.# 87168
K872932 · KNT
Mfg. and Research, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 15, 1987
GUIDING CATHETER
K873004 · DQO
Mallinckrodt Critical Care
Cardiovascular · 42d
Cleared Sep 15, 1987
MODIFIED VISIO-SEAL
K873069 · EBC
Espe GmbH (Us)
Dental · 40d