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
123889–123912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1990
QUALTEX SURGICAL DRAPE
K904960 · KKX
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Dec 13, 1990
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176 · DHB
Quidel Corp.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-LA (SS-B)
K905193 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-RO (SS-A)
K905194 · LKO
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
TURBIQUANT MYOGLOBIN
K905202 · DDR
Behring Diagnostics, Inc.
Immunology · 23d
Cleared Dec 13, 1990
1-CUT ACL GRAFT KNIFE
K905380 · GDX
Depuy, Inc.
General & Plastic Surgery · 13d
Cleared Dec 13, 1990
DISTAT ANTI-DSDNA KIT
K905386 · KTL
Shield Diagnostics, Ltd.
Immunology · 13d
Cleared Dec 12, 1990
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 12, 1990
MULTILASE 45
K904227 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 90d
Cleared Dec 12, 1990
MULTILASE 60
K904229 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 90d
Cleared Dec 12, 1990
KALTOSTAT WOUND DRESSING
K904488 · QSY
Calgon Vestal Div.
General & Plastic Surgery · 71d
Cleared Dec 12, 1990
NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
K904566 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Dec 12, 1990
NA NEEDLES
K904667 · GDM
Olympus Corp.
General & Plastic Surgery · 58d
Cleared Dec 12, 1990
HOOD, OPERATING, SURGICAL
K904969 · FXY
Chicago Assoc. For Retarded Citizens
General Hospital · 37d
Cleared Dec 11, 1990
OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH
K902295 · LYC
Ceramed Corp.
Dental · 203d
Cleared Dec 11, 1990
INTERVERTEBRAL DISC RONGEUR
K903151 · HAE
Von Zeppelin GmbH
Neurology · 146d
Cleared Dec 11, 1990
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
K904004 · CGS
Amresco, Inc.
Chemistry · 104d
Cleared Dec 11, 1990
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
K904209 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Dec 11, 1990
QUICKANCHOR (TM)
K904436 · GAS
Mitek Surgical Products, Inc.
General & Plastic Surgery · 74d
Cleared Dec 11, 1990
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · DIF
Medical Analysis Systems, Inc.
Chemistry · 42d
Cleared Dec 11, 1990
DISPOSABLE SURGICAL TOWEL (NON-STERILE)
K905005 · KKX
Marand Products, Inc.
General Hospital · 34d
Cleared Dec 11, 1990
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K905152 · IXR
Shimadzu Medical Systems
Radiology · 26d
Cleared Dec 11, 1990
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · IXR
Shimadzu Medical Systems
Radiology · 26d
Cleared Dec 11, 1990
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
K905226 · JGY
Enzyme Technology, Inc.
Chemistry · 21d