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
167833–167856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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