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
147289–147312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1985
NEWPORT VENTILATOR MODEL E-100
K852108
Newport Medical Instruments, Inc.
Cardiovascular · 126d
Cleared Sep 18, 1985
CLS HIP PROSTHESIS
K852517 · JDI
Advanced Biosearch Assn.
Orthopedic · 97d
Cleared Sep 18, 1985
OXY-DIAL
K852618 · BYF
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-ONE
K852623 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TWO
K852624 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TUBE
K852625 · CAT
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK ONE
K852626 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
NASAL ONE
K852628 · CAT
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK TWO
K852629 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
HUMPHREY FIELD ANALYZER MODEL 630
K852639 · HPT
Zeiss Humphrey System
Ophthalmic · 90d
Cleared Sep 18, 1985
ALGO I
K852687 · GWJ
Algotek, Inc.
Neurology · 85d
Cleared Sep 18, 1985
BAYLOR RAPID AUTOTRANSFUSION SYSTEM
K852736 · CAC
Cardio Systems, Inc.
Anesthesiology · 133d
Cleared Sep 18, 1985
MCGHAN TISSUE EXPANDER FILL KIT
K853014 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 63d
Cleared Sep 18, 1985
LIFELINC LEADWIRE
K853303 · BZQ
Tronomed, Inc.
Anesthesiology · 43d
Cleared Sep 18, 1985
H-H CATHETER PASSERS(TACL DESIGN
K853370 · GYK
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 18, 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K853371 · JXG
Holter-Hausner Intl.
Neurology · 37d
Cleared Sep 18, 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
K853548 · LCM
American Dade
Chemistry · 23d
Cleared Sep 18, 1985
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY
K853628 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared Sep 17, 1985
REVIVE SYSTEM
K844445 · LKY
Revive Systems Corp.
Gastroenterology & Urology · 305d
Cleared Sep 17, 1985
TELEFLEX GUIDEWIRE
K850677 · DQX
Teleflexmedical, Inc.
Cardiovascular · 208d
Cleared Sep 17, 1985
SONOLAYER-V, SSA-90A
K851036 · ITX
Toshiba Medical Systems
Radiology · 188d
Cleared Sep 17, 1985
SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
K851220 · KFZ
Northern Electric Co. Div. of Sunbeam...
Anesthesiology · 175d
Cleared Sep 17, 1985
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · DYG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 111d
Cleared Sep 17, 1985
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · GKZ
Abbott Diagnostics
Hematology · 105d