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
68881–68904 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · DYB
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jan 30, 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · KXK
Cp Medical
Radiology · 30d
Cleared Jan 30, 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
K034064 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Jan 30, 2004
PICCOLO MAGNESIUM TEST SYSTEM
K040115 · JGJ
Abaxis, Inc.
Chemistry · 10d
Cleared Jan 30, 2004
EMORY CARDIAC TOOLBOX VERSION 2.6
K040141 · KPS
Syntermed, Inc.
Radiology · 8d
Cleared Jan 29, 2004
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
K030418 · CBF
Makai Marine Industries, Inc.
Anesthesiology · 353d
Cleared Jan 29, 2004
HOLOTC RIA
K030655 · CDD
Axis-Shield Biochemicals, Asa
Chemistry · 332d
Cleared Jan 29, 2004
MEDONIC CA620/530 HEMATOLOGY ANALYZER
K032214 · GKZ
Boule Medical AB
Hematology · 192d
Cleared Jan 29, 2004
SCALETRON PIEZO ULTRASOUND SCALER
K033120 · ELC
Pac-Dent International (Suzhou), Ltd.
Dental · 121d
Cleared Jan 29, 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · FOZ
Becton, Dickinson & CO
General Hospital · 85d
Cleared Jan 29, 2004
CLEARFIL PROTECT BOND
K033938 · KLE
Kuraray Medical, Inc.
Dental · 41d
Cleared Jan 29, 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · DWF
Medtronic Vascular
Cardiovascular · 30d
Cleared Jan 29, 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · FRN
Abbott Laboratories
General Hospital · 9d
Cleared Jan 28, 2004
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
K023713 · KRC
Sontra Medical, Inc.
Cardiovascular · 450d
Cleared Jan 28, 2004
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
K031167 · MNW
Idt Technology Limited
Gastroenterology & Urology · 289d
Cleared Jan 28, 2004
SECUMAX BLOOD COLLECTION SYSTEM
K032141 · FMI
Tiger Meditech Incorporated
General Hospital · 201d
Cleared Jan 28, 2004
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · NBC
Biosite Incorporated
Chemistry · 191d
Cleared Jan 28, 2004
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K032263 · DZE
Implant Innovations, Inc.
Dental · 189d
Cleared Jan 28, 2004
RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
K032882 · MWJ
Recom Managed Systems, Inc.
Cardiovascular · 135d
Cleared Jan 28, 2004
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
K033349 · DQA
Masimo Corp.
Anesthesiology · 100d
Cleared Jan 28, 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS...
K033447 · NEU
Mri Devices Corp.
General & Plastic Surgery · 91d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 28, 2004
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
K033530 · LYY
Asia Pacific Latex Sdn Bhd
General Hospital · 79d
Cleared Jan 28, 2004
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K033532 · LYY
Asia Pacific Latex Sdn Bhd
General Hospital · 79d