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
88585–88608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1998
ANGIOLAZ VES-1CAM
K981819 · FWF
Angiolaz, Inc.
General & Plastic Surgery · 74d
Cleared Aug 04, 1998
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
K981907 · MRH
Peregrine Surgical , Ltd.
Ophthalmic · 64d
Cleared Aug 04, 1998
ANTAGON PORCELAIN
K982129 · EIH
European Dental Imports, Inc.
Dental · 48d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
K980106 · EIA
Proma, Inc.
Dental · 203d
Cleared Aug 03, 1998
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
K981181 · CHH
Actimed Laboratories, Inc.
Chemistry · 124d
Cleared Aug 03, 1998
DIRECT HDL
K981224 · LBS
Abbott Laboratories
Chemistry · 122d
Cleared Aug 03, 1998
DIRECT LDL
K981303 · MRR
Abbott Laboratories
Chemistry · 115d
Cleared Aug 03, 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · FRN
Alexander Mfg. Co.
General Hospital · 75d
Cleared Aug 03, 1998
ORTHOVU-1000
K981898 · LNH
Magnevu
Radiology · 63d
Cleared Aug 03, 1998
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE
K982015 · LYZ
Taian Plastics Products (Jingxing)...
General Hospital · 56d
Cleared Aug 03, 1998
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K982257 · LYZ
Taian Plastics Products (Jingxing)...
General Hospital · 38d
Cleared Aug 03, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K982284 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 34d
Cleared Aug 03, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K982285 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 34d
Cleared Aug 02, 1998
VITA TITANIUM PORCELAIN
K982664 · EIH
Vident
Dental · 2d
Cleared Jul 31, 1998
IMAGEQUEST
K974707 · LMD
Visual Med, Inc.
Radiology · 227d
Cleared Jul 31, 1998
EPIDURAL NEEDLE
K980536 · BSP
Manan Medical Products, Inc.
Anesthesiology · 170d
Cleared Jul 31, 1998
CALM
K980719 · HGM
Lms Medical Systems , Ltd.
Obstetrics & Gynecology · 157d
Cleared Jul 31, 1998
POLYCARBOXYLATE CEMENT
K980990 · EMA
Medental Intl.
Dental · 136d
Cleared Jul 31, 1998
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC...
K981397 · IYN
Toshiba America Medical Systems, In.C
Radiology · 105d
Cleared Jul 31, 1998
ULTRAPAK E
K981596 · MVL
Ultradent Products, Inc.
Dental · 88d
Cleared Jul 31, 1998
MTA MATERIAL II
K981620 · KIF
Dentsply Intl.
Dental · 86d
Cleared Jul 31, 1998
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)
K981627 · GEX
Xintec Corporation
General & Plastic Surgery · 85d