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
140377–140400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1987
MODIFIED C.P.R. MICROSHIELD
K871403 · CAE
Westmark Enterprises, Inc.
Anesthesiology · 26d
Cleared May 01, 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · EJR
Johnson & Johnson Professionals, Inc.
Dental · 185d
Cleared May 01, 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
K870403 · FOZ
Burron Medical Products, Inc.
General Hospital · 88d
Cleared May 01, 1987
IVT SOUTHWEST ALLERGY SCREEN
K870625 · DHB
In Vitro Technologies, Inc.
Immunology · 77d
Cleared May 01, 1987
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS
K870660 · JXG
Holter-Hausner Intl.
Neurology · 71d
Cleared May 01, 1987
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K870699 · JDI
Depuy, Inc.
Orthopedic · 71d
Cleared May 01, 1987
FRESENIUS HEMOFLOW F6 AND F8
K870725 · FJI
Seratronics, Inc.
Gastroenterology & Urology · 66d
Cleared May 01, 1987
SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE
K870793 · HCC
Self Regulation Systems, Inc.
Neurology · 64d
Cleared May 01, 1987
PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE
K870797 · EKX
Safco Dental Supply
Dental · 63d
Cleared May 01, 1987
DTV-411OP
K870869 · JAA
Adac Laboratories
Radiology · 59d
Cleared May 01, 1987
M10 EEG MONITOR SCOPE
K871120 · GYE
Telediagnostic Systems, Inc.
Neurology · 43d
Cleared May 01, 1987
DTV-4112 FLUOROSCOPIC TELEVISION CAMERA
K871127 · JAA
Adac Laboratories
Radiology · 42d
Cleared May 01, 1987
ARTHROSCOPIC MENISCAL SUTURE SYSTEM
K871323 · HWT
Orthopedic Systems, Inc.
Orthopedic · 28d
Cleared May 01, 1987
SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269
K871368 · IOQ
Schell B.V.
Physical Medicine · 24d
Cleared May 01, 1987
STD-228 SPECTRAL TREND DISPLAY
K871480 · GWS
Grass-Telefactor Product Group
Neurology · 17d
Cleared Apr 30, 1987
ALGINATE WOOL FIBER
K870383 · KHR
Adri
Dental · 90d
Cleared Apr 30, 1987
ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE
K871007 · FMF
Habley Medical Technology Corp.
General Hospital · 48d
Cleared Apr 30, 1987
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
K871154 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 30, 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 34d
Cleared Apr 30, 1987
AM CATH ESWL STENT
K871291 · FAD
Inter-Med Corp.
Gastroenterology & Urology · 30d
Cleared Apr 30, 1987
MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
K871464 · EFN
Medgroup Enterprises, Inc.
Dental · 16d
Cleared Apr 30, 1987
SWIVEL CONNECTORS #014452/#014453/#014459-120
K871540 · FPK
Clinical Connections, Inc.
General Hospital · 23d
Cleared Apr 30, 1987
MERIVAARA EMERGENCY PATIENT TROLLEY #436
K871556 · FPO
Global Medical Prods, Inc.
General Hospital · 8d
Cleared Apr 29, 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
K864128 · LJP
Diagnostic Technology, Inc.
Microbiology · 190d