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
163849–163872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 51d
Cleared Jul 10, 1981
NOVATRACER RECORDER
K811453 · DSF
Novametrix Medical Systems, Inc.
Cardiovascular · 49d
Cleared Jul 10, 1981
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20
K811501 · KCW
Rcx-Western, Inc.
General & Plastic Surgery · 44d
Cleared Jul 10, 1981
EPILATOR, BLEND-MODEL EB-200 & ET-1
K811503 · KCW
Rcx-Western, Inc.
General & Plastic Surgery · 44d
Cleared Jul 10, 1981
RADIATION BOLUS
K811528 · JAD
Action Products, Inc.
Radiology · 39d
Cleared Jul 10, 1981
MGN FEEDING TUBE
K811533 · KNT
Mgn Medical Manufacturing, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 10, 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · DXK
Diasonics, Inc.
Cardiovascular · 38d
Cleared Jul 10, 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · DGC
Ventrex Laboratories, Inc.
Chemistry · 38d
Cleared Jul 10, 1981
SIEMENS ANGIOTRON
K811587 · IXO
Siemens Corp.
Radiology · 35d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · FKP
Bd Becton Dickinson Vacutainer...
Chemistry · 32d
Cleared Jul 10, 1981
PREP-SITE PROTECTIVE DRESSING WIPE
K811625 · KMF
Acme United Corp.
General & Plastic Surgery · 31d
Cleared Jul 10, 1981
CIRAS ULTRASONIC SCANNING SYSTEM
K811633 · IYO
Ausonics Pty , Ltd.
Radiology · 31d
Cleared Jul 10, 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · LDD
Datascope Corp.
Cardiovascular · 30d
Cleared Jul 10, 1981
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · FRG
3M Company
General Hospital · 25d
Cleared Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · FIP
Gambro, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 10, 1981
SILASTIC TENDON PASSER H.P.
K811679 · HWQ
Dow Corning Corp. Healthcare...
Orthopedic · 25d
Cleared Jul 10, 1981
CIRCUIT, BREATHING
K811700 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 24d
Cleared Jul 10, 1981
QUANTIMUNE ESTRIOL RIA
K811709 · CGI
Bio-Rad
Chemistry · 23d
Cleared Jul 10, 1981
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
K811714 · DHN
Scripps-Miles, Inc.
Immunology · 23d
Cleared Jul 10, 1981
2M 9810 MICROWAVE OVEN
K811724 · LHF
Travenol Laboratories, S.A.
General Hospital · 22d
Cleared Jul 10, 1981
TBG DIAGNOSTIC KIT
K811725 · CEF
Immuno Assay Corp.
Chemistry · 22d
Cleared Jul 10, 1981
LEKSELL STEREOACTIC SYSTEM
K811726 · LHF
Downs Surgical , Ltd.
Radiology · 22d
Cleared Jul 10, 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · FRN
Biosearch Medical Products, Inc.
General Hospital · 21d
Cleared Jul 10, 1981
VIRGO IPA FOR DETECTION OF GENTAMICIN
K811744 · LCD
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d