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
172297–172320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1977
SINGLE & DUAL CHANNEL RECORDER
K772048 · DSF
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Nov 09, 1977
LINE CHARGER MODEL LC-100
K772053 · DRT
Datascope Corp.
Cardiovascular · 9d
Cleared Nov 08, 1977
LEWIS BLOOD GROUP SUBSTANCE
K771487 · KSX
Ortho Diagnostics, Inc.
Hematology · 95d
Cleared Nov 08, 1977
P1 BLOOD GROUP SUBSTANCE
K771488 · KSX
Ortho Diagnostics, Inc.
Hematology · 95d
Cleared Nov 07, 1977
NITROX 30 - ANESTHETIC GAS PROPORTIONER
K771479 · BSZ
Ohio Medical Products
Anesthesiology · 95d
Cleared Nov 07, 1977
SILASTIC BRAND INTRAVAGINAL TARSETTE
K771548 · HHW
Dow Corning Corp. Healthcare...
Obstetrics & Gynecology · 87d
Cleared Nov 07, 1977
KWICK KOOLER
K771660 · IMD
World Trade Assoc.
Physical Medicine · 69d
Cleared Nov 07, 1977
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · GKL
Technicon Instruments Corp.
Hematology · 54d
Cleared Nov 07, 1977
REAGENT CONFIDENCE SERA
K771814 · KSF
Ortho Diagnostics, Inc.
Hematology · 41d
Cleared Nov 07, 1977
STAC SYSTEM
K771821 · JJF
Technicon Instruments Corp.
Chemistry · 45d
Cleared Nov 07, 1977
ISO-SHIELD SALIVA ABSORBERS
K771908 · KHR
3M Company
Dental · 27d
Cleared Nov 07, 1977
RECORDER, DINMAP, MODEL 950
K771932 · DSH
Applied Medical Research
Cardiovascular · 24d
Cleared Nov 07, 1977
GINGITRACT
K771973 · EIG
Den-Mat Corp.
Dental · 21d
Cleared Nov 07, 1977
VIDEO ADAPTER FOR GRAPHIC RECORDERS
K772012 · IYO
Honeywell, Inc.
Radiology · 13d
Cleared Nov 03, 1977
DYNAZYME II GPT 340
K771152 · CKA
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Nov 03, 1977
DYNA ZYME II GOT 340
K771153 · CIT
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Nov 03, 1977
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · DPS
Hewlett-Packard Co.
Cardiovascular · 100d
Cleared Nov 03, 1977
AMIDO BLACK CONCENTRATE
K771720 · CEF
Sigma Chemical Co.
Chemistry · 51d
Cleared Nov 03, 1977
CREATININE
K771834 · CGX
Gamma Enterprises, Inc.
Chemistry · 43d
Cleared Nov 03, 1977
SERUM IRON
K771838 · JIY
Gamma Enterprises, Inc.
Chemistry · 43d
Cleared Nov 03, 1977
CPK COLOR TEST KIT
K771849 · CGS
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Nov 03, 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · CGX
Stanbio Laboratory
Chemistry · 35d
Cleared Nov 03, 1977
STAC SYSTEM-ADDI. ANALYTES
K771939 · JJF
Technicon Instruments Corp.
Immunology · 17d
Cleared Nov 03, 1977
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · DXG
Abbott Laboratories
Cardiovascular · 15d