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

Filters: Cleared only ×
176,076 results
168697–168720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1979
BLOOD UREA NITROGEN REAGENT
K792362 · JGZ
Connecticut Diagnostics, Ltd.
Chemistry · 15d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE I (HUMAN)
K792374 · JJW
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
ELEVATED LIPID CONTROL
K792375 · JJY
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
QUANTITATIVE CONTROL URINE II (HUMAN)
K792376 · JJW
Environmental Chemical Specialties
Chemistry · 10d
Cleared Dec 06, 1979
HEMOSPENSER CARTRIDGE CAT. NO. 523500-
K792378 · GDO
Edward Weck, Inc.
General & Plastic Surgery · 10d
Cleared Dec 06, 1979
PRINCIPAL ANALYTE REFERENCE SERUM
K792384 · JIX
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Dec 06, 1979
COTTON ROLL COMPRESSION CAPS
K792391 · EFN
Parker Laboratories, Inc.
Dental · 10d
Cleared Dec 06, 1979
ELVI CALCIUM
K792396 · CIA
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI ALBUMIN
K792408 · CIX
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL IRON BINDING CAPACITY
K792409 · JQF
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI SGOT & SGPT TRANSAMINASE
K792410 · CIS
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · CIG
Volu Sol Medical Industries
Chemistry · 10d
Cleared Dec 06, 1979
MW STRAIGHT ATTACHMENT
K792445 · EGS
Midwest
Dental · 6d
Cleared Dec 05, 1979
ACU-MED RED MISER HEMOTHORAX BLOOD COLL.
K791891 · CAC
Acumed Instruments Corp.
Anesthesiology · 71d
Cleared Dec 05, 1979
CONPHAR MANOMETER CONNECTORS
K792113 · DTL
Conphar, Inc.
Cardiovascular · 41d
Cleared Dec 05, 1979
CONTINUOUS FLUSH DEVICE
K792141 · KRA
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 44d
Cleared Dec 05, 1979
DISPOSA-HOOD
K792144 · FOG
Utah Medical Products, Inc.
Anesthesiology · 43d
Cleared Dec 05, 1979
AUTOMATIC RETRACTOR HOLDERS
K792145 · GAD
Automated Medical Products, Inc.
General & Plastic Surgery · 43d
Cleared Dec 05, 1979
HOWMEDICA MIX-KIT II
K792186 · JDZ
Howmedica Corp.
Orthopedic · 35d
Cleared Dec 05, 1979
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · KXA
Waldemar Link GmbH & Co. KG
Orthopedic · 34d
Cleared Dec 05, 1979
CURVED KUNTSCHER INTRAMEDULLARY NAIL
K792203 · HSB
Howmedica Corp.
Orthopedic · 33d
Cleared Dec 05, 1979
HOWMEDICA COMPRESSION STAPLE SYSTEM
K792204 · JDR
Howmedica Corp.
Orthopedic · 33d
Cleared Dec 05, 1979
HEARING AID, UNITRON MODEL 905W
K792237 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 29d
Cleared Dec 05, 1979
POLYCENTRIC TOTAL KNEE METAL TIBIAL
K792240 · HSX
Howmedica Corp.
Orthopedic · 28d