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
169033–169056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1979
TEMPO2-II DISPOSABLE THERMOMETERS
K790891 · FLK
Airlife, Inc.
General Hospital · 51d
Cleared Jun 27, 1979
I.V. TUBING ORGANIZER
K790901 · FPA
Acumed Instruments Corp.
General Hospital · 48d
Cleared Jun 27, 1979
INTEGRATED PATIENT STATIONS
K790902
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 48d
Cleared Jun 27, 1979
AUTOPAK CORTISOL TEST DELIVERY SYSTEM
K790906 · CGR
Micromedic Systems
Chemistry · 47d
Cleared Jun 27, 1979
AUTOPAK TEST DELIVERY SYSTEM
K790907 · CDX
Micromedic Systems
Chemistry · 47d
Cleared Jun 27, 1979
RIA, TEST SET CENTRIA T3
K790908 · CDP
Ventrex Laboratories, Inc.
Chemistry · 44d
Cleared Jun 27, 1979
RIA OF PROGESTERONE
K790911 · JLS
Calbiochem-Behring Corp.
Chemistry · 44d
Cleared Jun 27, 1979
JUHN TYM-TAP
K790915 · FMH
Xomed, Inc.
General Hospital · 44d
Cleared Jun 27, 1979
RADVIEW IMAGER SYSTEM
K790942 · JAK
General Electric Co.
Radiology · 40d
Cleared Jun 27, 1979
BORDISPO BRAND HYPODERMIC NEEDLE
K790953 · FMI
Borda Products, Inc.
General Hospital · 36d
Cleared Jun 27, 1979
CATHETER METAL HUB/RADIOPAQUE
K790967 · FOZ
Jelco Laboratories
General Hospital · 36d
Cleared Jun 27, 1979
ARGYLE URINE METER
K790969 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 36d
Cleared Jun 27, 1979
INSPIRON NEBULO TM 28 NEBULIZER KIT
K790982 · CAF
C.R. Bard, Inc.
Anesthesiology · 35d
Cleared Jun 27, 1979
C.C.F. FEMORAL DEBRIDEMENT PROBE
K790996 · HTO
Depuy, Inc.
Orthopedic · 29d
Cleared Jun 27, 1979
ULTICARE 2500 TREATMENT CHAIR
K791016 · FRK
American Health Care Industries, Inc.
General Hospital · 26d
Cleared Jun 27, 1979
FLUID ADMINISTRATION SET FA-3160
K791020 · EYN
Burron Medical Products, Inc.
General & Plastic Surgery · 26d
Cleared Jun 27, 1979
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34
K791069 · CAX
Union Carbide Corp.
Anesthesiology · 15d
Cleared Jun 27, 1979
ALLIGATOR FORECPTS, CUPPED FORCEPS
K791121 · JYR
Xomed, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 27, 1979
SURGICAL SCISSORS
K791124 · KBD
Xomed, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 27, 1979
PLUG-LOK CEMENT RESTIRCTOR
K791125 · LZN
Richard'S Medical Equip., Inc.
Orthopedic · 9d
Cleared Jun 27, 1979
360 HEMOCLIP APPLIERS
K791157 · GDO
Edward Weck, Inc.
General & Plastic Surgery · 6d
Cleared Jun 25, 1979
MIS AURAL ACOUSTIC SCREENER
K791170 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat
Cleared Jun 22, 1979
AMC R METACARPAL COMPONENT
K790793 · KWN
Howmedica Corp.
Orthopedic · 59d
Cleared Jun 22, 1979
DYNAJECT
K790835 · DXT
Atomic Products Corp.
Cardiovascular · 53d