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
125065–125088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1990
LABELLING CHANGES TO IMPRES-MB-X
K903508 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1990
SYNERMED TOTAL PROTEIN REAGENT KIT
K903511 · CEK
Synermed, Inc.
Chemistry · 35d
Cleared Sep 07, 1990
CURITY THORACENTESIS TRAY
K903569 · JOL
Kendall Healthcare Products Co....
General Hospital · 31d
Cleared Sep 07, 1990
REFLOTRON CREATININE TEST TABS
K903573 · JFY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 07, 1990
AIA-PACK IRI
K903628 · CFP
Tosoh Corp.
Chemistry · 28d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 87d
Cleared Sep 07, 1990
ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
K903767 · IYZ
Siemens Gammasonics, Inc.
Radiology · 18d
Cleared Sep 07, 1990
THE ON-GARD CORD-CADDY
K903855 · GEI
On-Gard Systems, Inc.
General & Plastic Surgery · 17d
Cleared Sep 06, 1990
PROPHY PASTE
K901580 · EJR
Dentsply Intl.
Dental · 155d
Cleared Sep 06, 1990
DEGUFLEX MONOPHASE
K901865 · ELW
Degussa AG
Dental · 135d
Cleared Sep 06, 1990
DEGUFLEX (R) CS PUTTY
K901867 · ELW
Degussa AG
Dental · 135d
Cleared Sep 06, 1990
LUHR MICRO MESH
K901940 · JEY
Howmedica Corp.
Dental · 129d
Cleared Sep 06, 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · JEY
Howmedica Corp.
Dental · 129d
Cleared Sep 06, 1990
DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES
K902066 · KNW
Endo-Scientific, Inc.
Gastroenterology & Urology · 121d
Cleared Sep 06, 1990
BAUER TEMNO BIOPSY NEEDLE
K902319 · FCG
Proact, Ltd.
Gastroenterology & Urology · 106d
Cleared Sep 06, 1990
SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*
K902348 · FYA
Futuristic Medical Concepts, Inc.
General Hospital · 104d
Cleared Sep 06, 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K902645 · DZB
Ormco Corp.
Dental · 83d
Cleared Sep 06, 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
K902646 · DZB
Ormco Corp.
Dental · 83d
Cleared Sep 06, 1990
DENTURE DYNAMIC'S DENTURE MAGIC
K902838 · EFT
Denture Dynamic'S, Inc.
Dental · 70d
Cleared Sep 06, 1990
TI-CORE (DENTAL COMPOSITE)
K902893 · EBF
Medical Device Inspection Co., Inc.
Dental · 66d
Cleared Sep 06, 1990
TITANIUM/STAINLESS STEEL INSTRUMENTS
K902911 · DZE
Impla-Med
Dental · 66d
Cleared Sep 06, 1990
ANTI-SCI-70 MICROASSAY
K902915 · LJM
Diamedix Corp.
Immunology · 65d
Cleared Sep 06, 1990
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · EJH
Vident
Dental · 57d
Cleared Sep 06, 1990
OLIVE K-WIRES
K903105 · JEC
Danek Medical, Inc.
Orthopedic · 63d