FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131017–131040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · DQX
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Jun 20, 1989
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639 · LJN
Diagnostic Technology, Inc.
Microbiology · 132d
Cleared Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · LDF
Daig Corp.
Cardiovascular · 123d
Cleared Jun 20, 1989
GUIDE WIRE INTRODUCER
K890807 · DQX
Datascope Corp.
Cardiovascular · 124d
Cleared Jun 20, 1989
HSV-CHECK(TM) TEST KIT
K890819 · HIS
Diagnostic Technology, Inc.
Microbiology · 123d
Cleared Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
K890827 · CHL
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Jun 20, 1989
PERIFLUX PF3
K890828 · DPW
Perimed, Inc.
Cardiovascular · 119d
Cleared Jun 20, 1989
SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
K890926 · FMI
Meadox Surgimed, Inc.
General Hospital · 116d
Cleared Jun 20, 1989
HSV-1 ELISA TEST SYSTEM
K891162 · GQL
Zeus Scientific, Inc.
Microbiology · 106d
Cleared Jun 20, 1989
DR. VOLKNER'S LAMELLAR TURNING BED(TM)
K891457 · FNM
James Consolidated, Inc.
General Hospital · 98d
Cleared Jun 20, 1989
EBNA-CHECK(TM) TEST KIT
K891542 · LLM
Diagnostic Technology, Inc.
Microbiology · 95d
Cleared Jun 20, 1989
HSV-2 ELISA TEST SYSTEM
K891782 · GQL
Zeus Scientific, Inc.
Microbiology · 88d
Cleared Jun 20, 1989
AMRESCO PRODUCT NUMBER 7426
K891923 · CFR
American Research Products Co.
Chemistry · 85d
Cleared Jun 20, 1989
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
K892005 · MKJ
Physio-Control Corp.
Cardiovascular · 84d
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · DSH
Edentec Corp.
Cardiovascular · 77d
Cleared Jun 20, 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331 · CDQ
American Monitor Corp.
Chemistry · 76d
Cleared Jun 20, 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818 · CFE
Helena Laboratories
Chemistry · 64d
Cleared Jun 20, 1989
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · CIT
Sigma Chemical Co.
Chemistry · 63d
Cleared Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · LCP
Helena Laboratories
Hematology · 54d
Cleared Jun 20, 1989
INTRA AORTIC BALLOON
K893243 · DSP
Datascope Corp.
Cardiovascular · 19d
Cleared Jun 20, 1989
L30-LB- INFANT LIMB BAND
K893245 · DRX
Contour Electrodes, Inc.
Cardiovascular · 53d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · DXG
Baxter Healthcare Corp
Cardiovascular · 50d
Cleared Jun 20, 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 49d
Cleared Jun 20, 1989
ARGENCO 60 TYPE IV DENTAL GOLD ALLOY
K893554 · EJT
Argen Precious Metals, Inc.
Dental · 43d