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
144481–144504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1986
DEMAND OXYGEN SAVER SYSTEM (D02S)
K861423 · BZQ
Applied Membrane Technology, Inc.
Anesthesiology · 30d
Cleared May 16, 1986
MIAMI-SUNNY
K861636 · FTC
Sunworld Corp.
General & Plastic Surgery · 17d
Cleared May 16, 1986
CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)
K861705 · FTC
Vita-Tan Corp.
General & Plastic Surgery · 11d
Cleared May 16, 1986
A TENS (MODEL AI-86)
K861709 · GZJ
American Imex
Neurology · 11d
Cleared May 16, 1986
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
K861711 · GDT
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 11d
Cleared May 16, 1986
REGAN-LOWE AGAR
K861734 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 10d
Cleared May 15, 1986
SHORT RAGWEED ALLERGEN DISC
K854756 · DHB
Immuno Nuclear Corp.
Immunology · 169d
Cleared May 15, 1986
MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER
K860235 · ITX
Hoffrel Instruments, Inc.
Radiology · 113d
Cleared May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · LLL
Immuno Concepts, Inc.
Immunology · 100d
Cleared May 15, 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · KNT
Acme United Corp.
Gastroenterology & Urology · 72d
Cleared May 15, 1986
ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
K860863 · LQC
George Percy Mcgown
Gastroenterology & Urology · 69d
Cleared May 15, 1986
JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
K860943 · KPL
Colon Therapeutics
Gastroenterology & Urology · 64d
Cleared May 15, 1986
DUTHOY STONE BASKET
K861469 · FFL
Lake Region Mfg., Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 1986
BARD DOUBLE PIGTAIL URETERAL STENT
K861478 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 14, 1986
NEO-TRAK 502 INFANT MONITOR
K861407 · BZQ
Ge Medical Systems Information...
Anesthesiology · 29d
Cleared May 14, 1986
CANON AUTO REF KERATOMETER RK-1
K861415
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
CANON AUTO ACUITOMETER CV-10
K861416 · HOX
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
K861535 · HMR
CooperVision, Inc.
Ophthalmic · 20d
Cleared May 13, 1986
AMUCHINA/DIALYZER DISINFECTANT
K852359 · FKQ
Amuchina Intl., Inc.
Gastroenterology & Urology · 343d
Cleared May 13, 1986
TRANSCOR (TM) RADIO-STETHOSCOPE
K854772 · DQD
K & S Medicorp
Cardiovascular · 165d
Cleared May 13, 1986
TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
K855176 · FBK
Urologic Surgical Devices Corp.
Radiology · 138d
Cleared May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · LIN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 119d
Cleared May 13, 1986
THE CMV-IGM TEST
K860450 · LKQ
Microbiological Research Corp.
Microbiology · 98d