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
144169–144192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1986
JEDMED MINI-MOS VIDEO CAMERA
K862145 · FWD
Jedmed Instrument Co.
General & Plastic Surgery · 9d
Cleared Jun 13, 1986
MEDTECH C.P.R. MASK
K862199 · CAE
The Medtech Group, Inc.
Anesthesiology · 3d
Cleared Jun 12, 1986
NEUROMETER
K853608 · LLN
Neurotron, Inc.
Neurology · 288d
Cleared Jun 12, 1986
VITAL FLOW NASAL CPAP SYSTEM
K860848 · BYE
Systems 2000, Inc.
Anesthesiology · 98d
Cleared Jun 12, 1986
PARENTERAL INFUSER MEDIPUMP 204
K861001 · FRN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 86d
Cleared Jun 12, 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · LJT
Medtronic Vascular
General Hospital · 50d
Cleared Jun 11, 1986
LSF* TOTAL HIP SYSTEM
K855017 · JDI
Implant Technology, Inc.
Orthopedic · 177d
Cleared Jun 11, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jun 11, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
K861819 · CGX
Eastman Kodak Company
Chemistry · 30d
Cleared Jun 11, 1986
CM-6 TOTAL HIP SYSTEM
K861930 · JDI
Kirschner Medical Corp.
Orthopedic · 22d
Cleared Jun 10, 1986
RICH-MAR IF 200
K854485 · IPF
Rich-Mar Corp.
Physical Medicine · 215d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
K860549 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jun 10, 1986
ERBIUM X-RAY FILTER
K860760 · ITY
Reactor Experiments, Inc.
Radiology · 102d
Cleared Jun 10, 1986
SURGI-TIE LOOPS
K861161
Healthmed Corp.
General & Plastic Surgery · 74d
Cleared Jun 10, 1986
WELCH ALLYN TYMPANOMETER
K861516 · ETY
Welch Allyn, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631 · JXA
Syn-Kit, Inc.
Microbiology · 42d
Cleared Jun 10, 1986
WEIGHTED ACQUISITION MODULE
K861637 · IYX
Siemens Gammasonics, Inc.
Radiology · 41d
Cleared Jun 10, 1986
AUTOFLUOR V
K861978 · KTL
Technia Diagnostics , Ltd.
Immunology · 20d
Cleared Jun 10, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
K861997 · JSK
Hazleton Research Products, Inc.
Microbiology · 18d
Cleared Jun 10, 1986
MENTOR FLAT-SPAN
K862049 · LCJ
Mentor Corp.
General & Plastic Surgery · 12d
Cleared Jun 10, 1986
NONWOVEN SURGICAL DRAPE PACK
K862062 · KKX
East Texas Lighthouse For the Blind
General Hospital · 11d
Cleared Jun 09, 1986
LIFESTAT 100
K853561 · DXN
Physio-Control Corp.
Cardiovascular · 287d
Cleared Jun 09, 1986
ELECTRO-MYOGRAPHIC PERINEOMETER
K854193 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 237d