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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74449–74472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2002
BRIGHT GOLD
K021892 · EJT
Ivoclar Vivadent, Inc.
Dental · 48d
Cleared Jul 25, 2002
CLARREN HELMET (ORTHOMERICA)
K021918 · OAN
Orthomerica Products, Inc.
Neurology · 44d
Cleared Jul 25, 2002
AUROPAL 60
K021926 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 43d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jul 25, 2002
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
K022085 · JJW
J & S Medical Assoc., Inc.
Chemistry · 28d
Cleared Jul 25, 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · JDI
Biomet, Inc.
Orthopedic · 28d
Cleared Jul 25, 2002
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
K022108 · JIX
Thermo Dma, Inc.
Chemistry · 27d
Cleared Jul 25, 2002
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
K022119 · EFB
Electro Medical Systems SA
Dental · 24d
Cleared Jul 25, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
K022129 · LON
Becton, Dickinson & CO
Microbiology · 24d
Cleared Jul 25, 2002
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
K022169 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 25, 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · HSB
Vector Medical, Inc.
Orthopedic · 15d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · HRS
Synthes (Usa)
Orthopedic · 13d
Cleared Jul 24, 2002
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K020004 · BZG
Compleware Corp.
Anesthesiology · 203d
Cleared Jul 24, 2002
PRISMAFLO
K020103 · KOC
Stihler Electronic GmbH
Gastroenterology & Urology · 194d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK
Bayer Corp.
Immunology · 132d
Cleared Jul 24, 2002
ENDOSSOUS IMPLANTS
K021322 · DZE
Intra-Lock International
Dental · 90d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · DSI
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · HRS
Synthes (Usa)
Orthopedic · 78d
Cleared Jul 24, 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · LPH
Hayes Medical, Inc.
Orthopedic · 78d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Jul 24, 2002
ABP FOR WINDOWS
K021517 · DSK
Rozinn Electronics, Inc.
Cardiovascular · 75d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Jul 24, 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE...
K021784 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 55d
Cleared Jul 24, 2002
HEARTLINE RECEIVING STATION
K022073 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 28d