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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171241–171264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1978
THERMAJUST CIRCU-TEMP
K780543 · JRQ
Techhnilab Instruments, Inc.
Chemistry · 53d
Cleared May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · CGO
Stanbio Laboratory
Chemistry · 53d
Cleared May 26, 1978
BOTTLE BREATHING DEVICE
K780558 · BYO
B & F Medical Products, Inc.
Anesthesiology · 51d
Cleared May 26, 1978
DURAN FLEXIBLE RING
K780568
Hancock Laboratories, Inc.
Cardiovascular · 46d
Cleared May 26, 1978
MASK, ISOLATION
K780609 · FXX
Abco Dealers, Inc.
General Hospital · 46d
Cleared May 26, 1978
CULDOCENTESIS TRAY
K780624 · GAA
Cutter Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared May 26, 1978
VENTURI OXYGEN MASK
K780626 · BYF
Hospitak, Inc.
Anesthesiology · 42d
Cleared May 26, 1978
ACCESSORY HDL CHOLESTEROL REAGENT SET
K780638 · CHH
The Dow Chemical Co.
Chemistry · 38d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 435
K780649 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
FLAME PHOTOMETER, MODEL 455
K780650 · JJO
Corning Medical & Scientific
Chemistry · 37d
Cleared May 26, 1978
MICRO-RING
K780711 · EGG
Howmedica Corp.
Dental · 29d
Cleared May 26, 1978
ADVANCED DENTURE SYSTEM
K780722 · EKO
Advanced Marketing Research Co.
Dental · 25d
Cleared May 26, 1978
SNAP-WAY
K780747 · DZB
Northwest Orthodontics, Inc.
Dental · 18d
Cleared May 26, 1978
PROPHYLAXIS ANGLE
K780752 · EGS
Young Dental Manufacturing Co. 1, LLC
Dental · 18d
Cleared May 26, 1978
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · DXE
Shiley, Inc.
Cardiovascular · 18d
Cleared May 26, 1978
MODEL 5621A INTERFACE
K780768 · DQK
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared May 26, 1978
TRIGLYCERIDE C-37 RAPID STAT KIT
K780825 · JGY
Pierce Chemical Co.
Chemistry · 7d
Cleared May 26, 1978
BILIRUBIN RAPID STAT KIT
K780826 · CIG
Pierce Chemical Co.
Chemistry · 7d
Cleared May 25, 1978
SONOGRAF EDP REAL-TIME ADAPTER
K780578 · IYO
Foley, Lardner, Hollabaugh & Jacobs
Radiology · 45d
Cleared May 25, 1978
GYNESURG
K780587 · KNA
Polamedco, Inc.
Obstetrics & Gynecology · 44d
Cleared May 19, 1978
MICROCELL COUNTER MODEL CC-108
K780224 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 105d
Cleared May 19, 1978
CARDIAC MINISCOPE & MINIGRAPH
K780297 · DRT
Arco Medical Products Co.
Cardiovascular · 87d
Cleared May 19, 1978
CARDIAC MINIGRAPH
K780307 · DPS
Arco Medical Products Co.
Cardiovascular · 87d
Cleared May 19, 1978
RP-510/RP-514 PARALLEL PLATE DIALYZERS
K780427 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 63d