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
77089–77112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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