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
78553–78576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · CAH
Allegiance Healthcare Corp.
General Hospital · 56d
Cleared Jun 08, 2001
ONE-STEP PLUS
K011159 · EMA
Bisco, Inc.
Dental · 58d
Cleared Jun 08, 2001
ULTRASOUND SCANNER, TYPE 2102
K011417 · IYO
B & K Medical A/S
Radiology · 30d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · LDP
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL...
K011494 · JJY
Bio-Rad
Immunology · 24d
Cleared Jun 08, 2001
INFANT FLOW SYSTEM, MODEL M672P
K011516 · BZD
Eme (Electro Medical Equipment) , Ltd.
Anesthesiology · 22d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG
Medtox Diagnostics, Inc.
Toxicology · 21d
Cleared Jun 08, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · MWI
Agilent Technologies, Inc.
Cardiovascular · 17d
Cleared Jun 08, 2001
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX
K011601 · BTA
Ardo Medical AG
General & Plastic Surgery · 15d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · DKZ
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · LAF
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
CARDIOCAM MODEL 9CSY0799
K011611 · KPS
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jun 08, 2001
LIFEJET PRINTER 400
K011617 · LMC
Ferrania S.P.A. Stabilimento DI Ferrania
Radiology · 14d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624 · JAA
GE Medical Systems
Radiology · 14d
Cleared Jun 07, 2001
XSCAN32 TELERADIOLOGY SOFTWARE
K002911 · LLZ
Radiographic Digital Imaging, Inc.
Radiology · 262d
Cleared Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
K010455 · KFF
Diagnostica-Stago
Hematology · 129d
Cleared Jun 07, 2001
SOLA 700,SOLA 500, SOLA 300
K010724 · FTD
Drager Medizintechnik GmbH
General & Plastic Surgery · 87d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · FYA
Standard Textile Co., Inc.
General Hospital · 83d
Cleared Jun 07, 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN...
K010862 · KGO
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Jun 07, 2001
HYCARE LATEX EXAMINATION GLOVE, POWDERED
K010875 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 76d
Cleared Jun 07, 2001
UNI-LASER 470
K010885 · GEX
Medart Corp.
General & Plastic Surgery · 76d
Cleared Jun 07, 2001
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K011001 · LWM
Satelec
Dental · 90d
Cleared Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · JIH
Dade Behring, Inc.
Chemistry · 63d
Cleared Jun 07, 2001
PARADIGM QUICK-SET INFUSION SET
K011071 · FPA
Maersk Medical A/S
General Hospital · 59d