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
135385–135408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1988
EMIT HVA CALIBRATOR KIT
K881943 · DKB
Syva Co.
Toxicology · 60d
Cleared Jul 08, 1988
EMIT HVA CONTROL KIT
K881944 · DIF
Syva Co.
Toxicology · 60d
Cleared Jul 08, 1988
LO-CORE NEEDLE
K882064 · FMI
Device Labs, Inc.
General Hospital · 52d
Cleared Jul 08, 1988
QM300 ALBUMIN ANTIBODY PACK
K882082 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
QM300 IGG ANTIBODY PACK
K882083 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
RESUSCITATOR VALVE ASSEMBLY W/FILTER
K882204 · CBP
Intertech/Ohio
Anesthesiology · 44d
Cleared Jul 08, 1988
WAKO(TM) CRP
K882374 · DCN
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Jul 08, 1988
KEVOR-CURETTE
K882404 · PCF
Euro-Med Intl.
Obstetrics & Gynecology · 28d
Cleared Jul 08, 1988
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446 · DEM
Technicon Instruments Corp.
Immunology · 24d
Cleared Jul 08, 1988
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · BSZ
Ohmeda Medical
Anesthesiology · 22d
Cleared Jul 08, 1988
ELAN-E DISPOSALBE DRAPE
K882494 · KKX
Dermacare Products, Inc.
General Hospital · 22d
Cleared Jul 08, 1988
UNIVERSALLY ADJUSTABLE ARMBOARD
K882524 · BTX
Karlin Technology, Inc.
General & Plastic Surgery · 21d
Cleared Jul 08, 1988
RADKOR, CST-18
K882563 · IYB
Radkor, Inc.
Radiology · 17d
Cleared Jul 08, 1988
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · JTW
Precision Dynamics Corp.
Microbiology · 17d
Cleared Jul 08, 1988
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620 · MSJ
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · DBI
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882622 · JFR
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
K882623 · JZH
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
APPOLLO BATH
K882669 · ILK
Electric Mobility Corp.
Physical Medicine · 11d
Cleared Jul 07, 1988
ANTI-CYTOKERATIN MONOCLONAL ANTIBODY
K864893 · LYE
Bd Becton Dickinson Vacutainer...
Pathology · 570d
Cleared Jul 07, 1988
CANNULA MODEL AR-6551
K881792 · HRX
Arthrex Arthroscopy Instruments, Inc.
Orthopedic · 72d
Cleared Jul 07, 1988
ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
K881923 · FTC
Ultraviolet Resources Intl.
General & Plastic Surgery · 59d
Cleared Jul 07, 1988
PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
K882381 · KGO
Pioneering Technologies, Inc.
General Hospital · 28d
Cleared Jul 06, 1988
BIOSIGN
K872867 · FRC
Clinical Technology Corp.
General Hospital · 351d