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
125041–125064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1990
FRAME, SPECTACLE
K903949 · HQZ
Eureka Optics, Inc.
Ophthalmic · 13d
Cleared Sep 07, 1990
SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE
K895810 · FMF
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP HYPODERMIC NEEDLE
K895811 · FMI
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP INTRAVENOUS CATHETER
K895812 · FOZ
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP INSULIN SYRINGES
K895980 · FMF
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SURGICAL COTTON GLOVES
K900425 · LYU
Allo Pro Corp.
General Hospital · 220d
Cleared Sep 07, 1990
OHMEDA UNIVERSAL PAC
K901117 · BSZ
Ohmeda Medical
Anesthesiology · 183d
Cleared Sep 07, 1990
F-24 FEMORAL HIP PROSTHESIS
K901687 · LWJ
Med-Tek Corp.
Orthopedic · 148d
Cleared Sep 07, 1990
DEGUFLEX (R) CS LIGHT
K901866 · ELW
Degussa AG
Dental · 136d
Cleared Sep 07, 1990
C3C AND C4 RID KITS
K902382 · CZW
The Binding Site, Ltd.
Chemistry · 100d
Cleared Sep 07, 1990
ACID PHOSPHOTASE REAGENT TEST AND KIT
K902543 · CKB
Crestat Diagnostics, Inc.
Chemistry · 93d
Cleared Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
K902561 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 07, 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 78d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834 · CEC
Abbott Laboratories
Chemistry · 71d
Cleared Sep 07, 1990
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
K902976 · GZL
Medical Consultants Intl. , Ltd.
Neurology · 63d
Cleared Sep 07, 1990
MILENIA (TM) AMPHETAMINE
K902979 · DKZ
Diagnostic Products Corp.
Chemistry · 67d
Cleared Sep 07, 1990
MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL
K903204 · LNH
Summit World Trade Corp.
Radiology · 49d
Cleared Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
K903309 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
K903310 · JJY
Medical Analysis Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · JLW
Bio-Rad
Chemistry · 45d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
K903338 · JJY
Kenlor Industries, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 38d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432 · CDP
Abbott Laboratories
Chemistry · 38d