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
57865–57888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2007
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186 · HRS
Synthes (Usa)
Orthopedic · 34d
Cleared Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · MMI
bioMerieux, Inc.
Chemistry · 414d
Cleared Dec 14, 2007
PLASMAIR, MODEL T2006
K070722 · FRF
Airinspace B.V.
General Hospital · 274d
Cleared Dec 14, 2007
FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
K071353 · KLC
Shanghai Foshion Medical Instruments...
Dental · 213d
Cleared Dec 14, 2007
SMARTSITE STOPCOCK
K071400 · FMG
Cardinal Health, Alaris Products
General Hospital · 207d
Cleared Dec 14, 2007
AMIGO INSULIN PUMP
K071613 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 184d
Cleared Dec 14, 2007
WEINMANNCOMPACT, MODEL WM 27380
K072009 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 144d
Cleared Dec 14, 2007
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · LPH
Encore Medical, L.P.
Orthopedic · 133d
Cleared Dec 14, 2007
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
K072377 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 112d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 101d
Cleared Dec 14, 2007
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 95d
Cleared Dec 14, 2007
SYSTEM-ARMS, MODEL 390,E60
K072553 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 95d
Cleared Dec 14, 2007
PATIENT SAFE SYRINGE
K072654 · FMF
Retractable Technologies, Inc.
General Hospital · 85d
Cleared Dec 14, 2007
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE...
K072657 · LJT
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 14, 2007
MERILAS 532A
K072823 · HQF
Meridian AG
Ophthalmic · 73d
Cleared Dec 14, 2007
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
K072832 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Dec 14, 2007
SET PP
K073043 · EMA
Sdi , Ltd.
Dental · 46d
Cleared Dec 14, 2007
HYALOMATRIX PA
K073251 · QSZ
Fidia Advanced Biopolymers Srl
General & Plastic Surgery · 25d
Cleared Dec 14, 2007
AIR-FLOW MASTER STANDARD
K073284 · EFB
(Ems Sa) Electro Medical Systems
Dental · 23d
Cleared Dec 14, 2007
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
K073409 · GEX
Omniguide, Inc.
General & Plastic Surgery · 10d
Cleared Dec 13, 2007
FD EMS, MODEL # D-FJ30E
K063642 · IPF
Fuji Dynamics Limited
Physical Medicine · 371d
Cleared Dec 13, 2007
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
K070225 · DSP
Abiomed, Inc.
Cardiovascular · 323d
Cleared Dec 13, 2007
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · HIF
Sopro
Obstetrics & Gynecology · 267d
Cleared Dec 13, 2007
PURITAN BENNETT LEGENDAIR XL2
K070899 · CBK
Nellcor Puritan Bennett
Anesthesiology · 255d