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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69025–69048 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · KNQ
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Jan 13, 2004
SURGICAL MEDICAL DEVICE CAUTERY
K023506 · HQP
Modern Medical Equipment Mfg., Ltd.
Ophthalmic · 452d
Cleared Jan 13, 2004
IBL C3D-CIC EIA TEST
K032796 · CZW
Ibl GmbH
Immunology · 127d
Cleared Jan 13, 2004
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
K032966 · HWC
Simplicity Orthopedic Solutions, LLC
Orthopedic · 112d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Jan 13, 2004
MED-LOGICS, MODEL ML7090
K033293 · HNO
Med-Logics, Inc.
Ophthalmic · 91d
Cleared Jan 13, 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
K033312 · NKB
Ebi, L.P.
Orthopedic · 91d
Cleared Jan 13, 2004
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT...
K033323 · DTZ
Dideco S.P.A.
Cardiovascular · 90d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared Jan 13, 2004
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
K033569 · KRA
Flowmedica, Inc.
Cardiovascular · 62d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT...
K033850 · JXG
Medtronic Neurosurgery
Neurology · 33d
Cleared Jan 12, 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · KNQ
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 277d
Cleared Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
K032332 · LBZ
Roche Diagnostics Corp.
Toxicology · 167d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · KLR
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Jan 12, 2004
ENDOPURE ROOT CANAL CLEANSER
K032361 · KJJ
Dentsply Intl.
Dental · 165d
Cleared Jan 12, 2004
BIOCENTREX CARDIAC PANEL
K033155 · MYT
Biocentrex
Chemistry · 104d
Cleared Jan 12, 2004
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
K033286 · HSB
Orthopedic Designs, Inc. (Odi)
Orthopedic · 90d
Cleared Jan 12, 2004
MEDICAL MAGGOTS
K033391 · NQK
Ronald A. Sherman
General & Plastic Surgery · 81d
Cleared Jan 12, 2004
ACL TOP MODEL, TOP
K033414 · GKP
Instrumentation Laboratory CO
Hematology · 77d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...
K033525 · DCF
Dade Behring, Inc.
Chemistry · 66d
Cleared Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742 · DQX
Boston Scientific Corp
Cardiovascular · 45d
Cleared Jan 12, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033929 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d
Cleared Jan 09, 2004
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG,...
K032051 · MKJ
Access Battery, Inc.
Cardiovascular · 191d
Cleared Jan 09, 2004
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
K032585 · HDC
Ron-Tech Medical , Ltd.
Radiology · 141d