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
158713–158736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1982
PIO ROOT CANAL INDICATOR
K822793 · EIL
National Patent Development Corp.
Dental · 36d
Cleared Oct 22, 1982
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · CBH
Respironics, Inc.
Anesthesiology · 36d
Cleared Oct 22, 1982
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
K822815 · FFT
Del Mar Avionics
Gastroenterology & Urology · 32d
Cleared Oct 22, 1982
DUAL SERVO HEATED RESPIRATORY HUMIDIFIER
K822816 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 32d
Cleared Oct 22, 1982
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 29d
Cleared Oct 22, 1982
MODEL BX-3000 OXYGEN CONCENTRATOR
K822871 · CAW
Healthdyne, Inc.
Anesthesiology · 25d
Cleared Oct 22, 1982
MODEL #6200 OXYGEN CONCENTRATOR
K822889 · CAW
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 24d
Cleared Oct 22, 1982
G.E.V. DISPOSABLE SCALPELS
K822893 · GDX
Ascep, Inc.
General & Plastic Surgery · 24d
Cleared Oct 22, 1982
CAVIDRY
K822896 · EJH
Parker Laboratories, Inc.
Dental · 23d
Cleared Oct 22, 1982
ANAZYME ANA PEROXIDASE TEST SYSTEM
K822911 · DAA
Clinical Sciences, Inc.
Immunology · 21d
Cleared Oct 22, 1982
RX BIOCAST
K822948 · EJH
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
RX SFC
K822949 · EJT
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
RX UNIVERSAL
K822950 · EJS
Jeneric Ind.
Dental · 18d
Cleared Oct 22, 1982
ENDOSCOPIC VIDEOSYSTEM
K822959 · FET
Eder Instrument Co, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 21, 1982
BECKMAN ASTRA
K822039 · JGS
Beckman Instruments, Inc.
Chemistry · 101d
Cleared Oct 21, 1982
AMNISTAT-FLM
K822150 · JHG
Hana Biologics, Inc.
Hematology · 91d
Cleared Oct 21, 1982
DESERET ARTERIAL BLOOD SAMPLING KIT
K822248 · CBT
Warner-Lambert Co.
Anesthesiology · 84d
Cleared Oct 21, 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417 · CHH
Sclavo, Inc.
Chemistry · 71d
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658 · FKX
Abbott Laboratories
Gastroenterology & Urology · 48d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · FKX
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Oct 21, 1982
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · CFT
Abbott Laboratories
Chemistry · 37d
Cleared Oct 21, 1982
MDM ARTERIAL BLOOD GAS KIT
K822786 · CBT
Martell Medical Products, Inc.
Anesthesiology · 36d
Cleared Oct 21, 1982
YOSHIDA/KAYCOR X-70 X-RAY UNIT
K828325
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 23d
Cleared Oct 20, 1982
FACE SHIELDS
K822004 · KNT
Kelleher Corp.
Gastroenterology & Urology · 104d