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
168673–168696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1979
SEIDEL INTRAMEDULLARY PLUG
K792205 · HWC
Howmedica Corp.
Orthopedic · 34d
Cleared Dec 06, 1979
VANCE MALLEABLE TIP FILIFORM
K792219 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
VANCE KIDNEY BIOPSY BRUSHES
K792220 · KOD
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
VANCE PHILIPS FOLLOWER CATHETER & BOUGIE
K792221 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
CENTRIA CORTISOL RIA TEST SET
K792243 · CGR
Ventrex Laboratories, Inc.
Chemistry · 29d
Cleared Dec 06, 1979
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
K792254 · JFL
Nova Biomedical Corp.
Chemistry · 28d
Cleared Dec 06, 1979
KEITHLEY CLAMP
K792256 · EYR
Keithley Development Co.
General & Plastic Surgery · 27d
Cleared Dec 06, 1979
AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM
K792279 · CFP
Micromedic Systems
Chemistry · 23d
Cleared Dec 06, 1979
TECHNICON C800 SYSTEM
K792285 · JJC
Technicon Instruments Corp.
Chemistry · 23d
Cleared Dec 06, 1979
TSH STANDARDS & DILUENT
K792290 · JIT
Amersham Corp.
Chemistry · 23d
Cleared Dec 06, 1979
SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES
K792291 · KTW
Synthes (Usa)
Orthopedic · 23d
Cleared Dec 06, 1979
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · JJQ
Miles Laboratories, Inc.
Chemistry · 23d
Cleared Dec 06, 1979
CONCEP-7-BHCG
K792308 · JHI
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Dec 06, 1979
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K792314 · FAM
Icl Scientific
Immunology · 20d
Cleared Dec 06, 1979
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319 · LBS
Coulter Electronics, Inc.
Chemistry · 17d
Cleared Dec 06, 1979
XOMED MICROSURGERY BACKGROUND
K792330
Xomed, Inc.
General & Plastic Surgery · 17d
Cleared Dec 06, 1979
DAVOL/SIMON DERMATOME
K792332 · GFD
Davol, Inc.
General & Plastic Surgery · 17d
Cleared Dec 06, 1979
DONNECT. DIAG. CALCIUM DIAG. REAGENT
K792337 · CIC
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS
K792338 · CIG
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN
K792339 · CIX
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE
K792340 · CEK
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared Dec 06, 1979
TWO MINUTE PROTEINTEST
K792346 · CEK
Panmed, Inc.
Chemistry · 17d
Cleared Dec 06, 1979
MICRO LOWRY PROTEINTEST
K792347 · JGP
Panmed, Inc.
Chemistry · 17d
Cleared Dec 06, 1979
SYNTHES CERVICAL VERTABRAE PLATES
K792352 · KWQ
DePuy Synthes
Orthopedic · 17d