FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77593–77616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2001
GLYCOSAL II HBA 1C TEST
K011933 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 135d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · KNT
Zevex, Inc.
Gastroenterology & Urology · 115d
Cleared Nov 02, 2001
KADANCE 2000
K012492 · LBB
Kada Research, Inc.
Neurology · 91d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Nov 02, 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · HRX
Sterilmed, Inc.
Orthopedic · 87d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546 · KPR
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DEEP GRAY
K012563 · LLZ
Cortechs Labs, Inc.
Radiology · 85d
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Nov 02, 2001
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE...
K012626 · DQA
Osi Medical, Inc.
Anesthesiology · 81d
Cleared Nov 02, 2001
ICONNECTION 3D
K012779 · LLZ
Hinnovation, Inc.
Radiology · 74d
Cleared Nov 02, 2001
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS
K012829 · KQO
Biocare Corp.
Chemistry · 71d
Cleared Nov 02, 2001
PORTADUR P 2, MODEL #2031
K012843 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 71d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Nov 02, 2001
VARICES INJECTION NEEDLE
K012977 · FBK
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Nov 02, 2001
MINIME NASAL MASK, MODEL P/N 50220
K013306 · BZD
Sleepnet Corporation
Anesthesiology · 29d
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