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
105313–105336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1994
MICROREADER 4
K935983 · JJQ
Hyperion, Inc.
Chemistry · 360d
Cleared Dec 09, 1994
MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM
K940660 · IYE
Victoreen, Inc.
Radiology · 297d
Cleared Dec 09, 1994
LENZAR REMOTE ACQUISITION SYSTEM
K941224 · LMD
Lenzar Electrooptics, Inc.
Radiology · 270d
Cleared Dec 09, 1994
PHOSPHATE QVET
K942960 · CEO
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
AMYLASE QVET
K942961 · JFJ
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
CALCIUM QVET
K943003 · CJJ
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
TOTAL PROTEIN QVET
K943004 · CEK
Prisma Systems
Chemistry · 169d
Cleared Dec 09, 1994
POTASSIUM QVET
K943026 · CEJ
Prisma Systems
Chemistry · 165d
Cleared Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 128d
Cleared Dec 09, 1994
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134 · KZM
Myo-Tronics, Inc.
Dental · 107d
Cleared Dec 09, 1994
POWDER FREE MEDICAL GLOVE
K944182 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 105d
Cleared Dec 09, 1994
SYNTHETIC MEDICAL GLOVES
K944184 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 105d
Cleared Dec 09, 1994
APR II NON POROUS HIP STEM
K944209 · LZO
Intermedics Orthopedics
Orthopedic · 102d
Cleared Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · HWC
Howmedica Corp.
Orthopedic · 102d
Cleared Dec 09, 1994
OLYMPUS AMYLASE REAGENT
K944229 · JFJ
Olympus America, Inc.
Chemistry · 100d
Cleared Dec 09, 1994
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared Dec 09, 1994
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
K944490 · CGI
Wallac OY
Toxicology · 87d
Cleared Dec 09, 1994
THYROXINE ENZYME IMMUNOASSAY
K944703 · KLI
Diagnostic Reagents, Inc.
Chemistry · 77d
Cleared Dec 09, 1994
IMX T3 ASSAY
K944808 · CDP
Organon Teknika Corp.
Chemistry · 71d
Cleared Dec 09, 1994
POLYURETHANE SOLUTION 29% W/W
K944934 · LBH
Knowell Therapeutic Technologies,Inc.
Dental · 64d
Cleared Dec 09, 1994
TOMO-LINK
K944967 · IZF
GE Medical Systems
Radiology · 59d
Cleared Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
K945194 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 09, 1994
ABUSCREEN ONLINE PROPOXPHENE
K945195 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 09, 1994
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
K945287 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 39d