Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
169873–169896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1979
PULSE GENERATOR MODEL 629
K790670 · DXY
Elema-Schonander, Inc.
Cardiovascular · 82d
Cleared Jun 27, 1979
DELTA PUMP
K790814 · FRN
Spiess Design, Inc.
General Hospital · 61d
Cleared Jun 27, 1979
REPGREEN ULTRAFILTRATION MONITOR
K790824 · FIL
Cyberex Corp.
Gastroenterology & Urology · 57d
Cleared Jun 27, 1979
TG 2, TRI-GARD PRESSURE MONITOR
K790841 · KOC
Sorensen Research
Gastroenterology & Urology · 56d
Cleared Jun 27, 1979
TRACH T WITH ONE-WAY VALVES
K790888 · BZA
Airlife, Inc.
Anesthesiology · 51d
Cleared Jun 27, 1979
TEMPO2-I DISPOSABLE THERMOMETERS
K790890 · FQZ
Airlife, Inc.
General Hospital · 51d
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