FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142657–142680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1986
WYLER SPHENOIDAL ELECTRODE
K861031 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 160d
Cleared Aug 25, 1986
DAKO ITA SYSTEM
K861059 · DEW
Dako Corp.
Immunology · 159d
Cleared Aug 25, 1986
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 124d
Cleared Aug 25, 1986
860 COLOR DOPPLER OR COLORVIEW 860
K861538 · IYO
Ge Medical Systems Information...
Radiology · 123d
Cleared Aug 25, 1986
LIFESCAN EVOKED POTENTIAL SYSTEM
K861900 · GWF
Neurometrics
Neurology · 101d
Cleared Aug 25, 1986
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
K861981 · DRW
Vital Signs, Inc.
Cardiovascular · 95d
Cleared Aug 25, 1986
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
K862056 · DQY
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Aug 25, 1986
AMNIOINFUSION CATHETER
K862182 · KXO
Michael Reese Hospital and Medical...
Obstetrics & Gynecology · 77d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244 · DQO
Cordis Corp.
Cardiovascular · 74d
Cleared Aug 25, 1986
CORNEAL MODELING SYSTEM
K862379 · HJO
Computed Anatomy, Inc.
Ophthalmic · 62d
Cleared Aug 25, 1986
MINI-HOLTER, MODEL 2000
K862526 · DSH
Holter Recorders
Cardiovascular · 54d
Cleared Aug 25, 1986
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
K862748 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 35d
Cleared Aug 25, 1986
SARA RT
K862880 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 26d
Cleared Aug 25, 1986
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
K862953 · DRY
Classic Medical Products, Inc.
Cardiovascular · 20d
Cleared Aug 25, 1986
MICRA MICROSURGICAL INSTRUMENTS
K862971 · GZX
Cordis Corp.
Neurology · 19d
Cleared Aug 21, 1986
KEELER DUAL LIGHTSOURCE
K861746 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
KEELER FIBEROPTIC HEADLAMP
K861747 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
FORMOSTAR
K862106 · IRT
Lmv, Liske & Methling, GmbH
Physical Medicine · 80d
Cleared Aug 21, 1986
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
K862188 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 73d
Cleared Aug 21, 1986
PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010
K862213
Lifestream Int'L, Inc.
General & Plastic Surgery · 72d
Cleared Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
K862321 · LKT
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Aug 21, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Aug 21, 1986
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641 · KHG
U. S. Diagnostics, Inc.
Hematology · 41d
Cleared Aug 21, 1986
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692 · HKS
Ocular Instruments, Inc.
Ophthalmic · 37d