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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78217–78240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2001
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC,...
K013326 · DSP
Datascope Corp.
Cardiovascular · 28d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · CEM
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · KPR
GE Medical Systems
Radiology · 14d
Cleared Nov 01, 2001
DIACLEAR ULTRAFILTER
K003957 · FIP
Gambro Renal Products
Gastroenterology & Urology · 315d
Cleared Nov 01, 2001
W.O.M. LASER U100
K011175 · GEX
W.O.M. World of Medicine GmbH
General & Plastic Surgery · 198d
Cleared Nov 01, 2001
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
K011796 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 146d
Cleared Nov 01, 2001
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · DQD
American Diagnostic Corp.
Cardiovascular · 104d
Cleared Nov 01, 2001
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
K012498 · DXN
Pulse Metric, Inc.
Cardiovascular · 90d
Cleared Nov 01, 2001
CEREC3 VITABLOCKS
K012517 · ELW
Sirona Dental Systems GmbH
Dental · 87d
Cleared Nov 01, 2001
KSEA SIALOENDOSCOPES AND ACCESSORIES
K012527 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared Nov 01, 2001
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
K012761 · EBC
Prime Dental Manufacturing, Inc.
Dental · 76d
Cleared Nov 01, 2001
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
K012767 · ELW
S & C Polymer GmbH
Dental · 76d
Cleared Nov 01, 2001
BIOPORTA G, MODEL 2052
K012826 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA AURIUM, MODEL 2067
K012827 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA SMK 82, MODEL 2032
K012828 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
BIO PORTADUR, ORDER-NO.:2017
K012831 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA GEO TI MODEL #2004
K012834 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Nov 01, 2001
PORTA MAXIMUM, MODEL# 2066
K012835 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 70d
Cleared Oct 31, 2001
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION...
K010202 · GXD
Leslie W. Organ
Neurology · 282d
Cleared Oct 31, 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · KDI
Gambro Renal Products
Gastroenterology & Urology · 194d
Cleared Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE...
K011761 · DYB
Arrow Intl., Inc.
Cardiovascular · 147d
Cleared Oct 31, 2001
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40...
K011916 · MSD
Horizon Medical Products, Inc.
Gastroenterology & Urology · 133d
Cleared Oct 31, 2001
OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS
K012495 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Oct 31, 2001
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH...
K012714 · LYY
Koon Seng Sdn Bhd
General Hospital · 78d