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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133345–133368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1988
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
K882138 · DPW
Imex Medical Systems, Inc.
Cardiovascular · 171d
Cleared Nov 07, 1988
STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY
K882875 · IZH
Lorad Medical Systems, Inc.
Radiology · 119d
Cleared Nov 07, 1988
DITTMAR POWER LIFTER
K883260 · FOX
Dittmar and Penn Corp.
General Hospital · 96d
Cleared Nov 07, 1988
OPTIMED ADVANTAGE
K883458 · HPT
Optimed, Inc.
Ophthalmic · 87d
Cleared Nov 07, 1988
THERMOMETER, MERCURY/CLINICAL
K883573 · FLK
Umax Corp.
General Hospital · 77d
Cleared Nov 07, 1988
LUM VASCULAR PROCEDURE SYSTEM #B5200A
K883664 · IYB
General Electric Co.
Radiology · 73d
Cleared Nov 07, 1988
REUSABLE ADULT INCONTINENT DIAPER
K883787 · EYQ
Intera Corp.
Gastroenterology & Urology · 61d
Cleared Nov 07, 1988
ERGO II, SURGICAL LATEX GLOVES
K884030 · KGO
Ergo Intl., Ent., Inc.
General Hospital · 45d
Cleared Nov 07, 1988
CRITICAL CARE I.V. STAND STABILIZING BRACKET
K884341 · FOX
Rbd Medical, Inc.
General Hospital · 24d
Cleared Nov 07, 1988
CMS IV EXTENSION SETS
K884370 · FPK
Churchill Medical Systems, Inc.
General Hospital · 20d
Cleared Nov 04, 1988
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
K874096 · DTK
Medi-Tech, Inc.
Cardiovascular · 393d
Cleared Nov 04, 1988
OLV 1100
K881307 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 221d
Cleared Nov 04, 1988
PORT-O-HEAT, MODEL 0100
K882151 · IRT
Arthotronics, Inc.
Physical Medicine · 165d
Cleared Nov 04, 1988
NIOBI-X RADIATION REDUCTION FILTER
K882939 · ITY
American Canadian Products, Inc.
Radiology · 114d
Cleared Nov 04, 1988
FORCE GUARD I
K882974 · IRN
Boulder Impact Monitors, Inc.
Physical Medicine · 112d
Cleared Nov 04, 1988
HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE
K883481 · IYO
Hewlett-Packard Co.
Radiology · 80d
Cleared Nov 04, 1988
ICOR AGENT MONITOR
K883532 · CBQ
Icor AB
Anesthesiology · 78d
Cleared Nov 04, 1988
QM300 CONTROL E
K883537 · DHB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 78d
Cleared Nov 04, 1988
METALASER VASCULASE
K883541 · GEX
Metatech Corp.
General & Plastic Surgery · 77d
Cleared Nov 04, 1988
CORONARY GUIDE WIRE
K883579 · DQX
Datascope Corp.
Cardiovascular · 74d
Cleared Nov 04, 1988
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
K883722 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Nov 04, 1988
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · KPR
Medrad, Inc.
Radiology · 56d
Cleared Nov 04, 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Nov 04, 1988
MEDITEC QL-15 ND:YAG LASER
K884060 · GEX
Storz Ophthalmics, Inc.
General & Plastic Surgery · 39d