FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93673–93696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916 · LDJ
Diagnostic Products Corp.
Toxicology · 210d
Cleared Apr 28, 1997
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K964119 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400 · KTT
Alphatec Mfg., Inc.
Orthopedic · 175d
Cleared Apr 28, 1997
IMMERGE IMAGE CORRELATION
K970623 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 68d
Cleared Apr 28, 1997
CAP-35B III/CINE 275
K971128 · IXR
Jamieson Film Co.
Radiology · 32d
Cleared Apr 28, 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
K971141 · CEC
Dade Chemistry Systems, Inc.
Chemistry · 31d
Cleared Apr 28, 1997
ADVENTURER
K971142 · IOR
T.E.S., Ltd.
Physical Medicine · 31d
Cleared Apr 25, 1997
VENTANA ANTI-S100 PRIMARY ANTIBODY
K941514 · DEH
Ventana Medical Systems, Inc.
Immunology · 1123d
Cleared Apr 25, 1997
SIMPLEX TENS
K953982 · GZJ
Armstrong Industries, Inc.
Neurology · 611d
Cleared Apr 25, 1997
DRAGER INCUBATOR 8000 IC
K954204 · FMZ
Drager, Inc.
General Hospital · 597d
Cleared Apr 25, 1997
SPACELABS MEDICAL ECG ANALYSIS SYSTEM
K962930 · DQK
Spacelabs Medical, Inc.
Cardiovascular · 270d
Cleared Apr 25, 1997
PARAMAX SALICYLATE REAGENT
K964715 · DKJ
Dade Intl., Inc.
Toxicology · 151d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · DDB
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · DEM
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
VSA 3000 VIBRATORYN SENSORY ANALYZER
K970180 · LLN
Eare Consulting Service
Neurology · 98d
Cleared Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
K970303 · IXI
General Electric Co.
Radiology · 88d
Cleared Apr 25, 1997
MODIFIED E-PACK PROCEDURE KIT
K970317 · GAM
Ethicon, Inc.
General & Plastic Surgery · 88d
Cleared Apr 25, 1997
NATURE'S CRADLE
K970334 · FMS
Infant Advantage, Inc.
General Hospital · 87d
Cleared Apr 25, 1997
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
K970380 · FMI
Pyng Medical Corp.
General Hospital · 81d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
K970593 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
ETEST SPARFLOXACIN
K970820 · JWY
Ab Biodisk
Microbiology · 50d
Cleared Apr 25, 1997
ACCULINE PREGNANCY TEST
K971122 · JHI
Genix Biotek, Inc.
Chemistry · 29d
Cleared Apr 24, 1997
SAFE-CATH
K960764 · FOZ
Scientific Device Manufacturer, LLC
General Hospital · 423d