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
117073–117096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1992
OHMEDA MODEL 5250 RGM MONITOR
K920590 · CCK
Ohmeda Medical
Anesthesiology · 203d
Cleared Aug 31, 1992
CERAMIC FEMORAL HEAD
K920593 · LZO
Dow Corning Wright
Orthopedic · 202d
Cleared Aug 31, 1992
THERMA-H
K921189 · LKX
Zewa AG
Gastroenterology & Urology · 181d
Cleared Aug 31, 1992
MODIFIED SITE MACROBORE PHACO NEEDLE
K922595 · HQC
Chiron Vision Corp.
Ophthalmic · 90d
Cleared Aug 31, 1992
CUTINOVA FOAM
K922681 · KMF
Jobst Institute, Inc.
General & Plastic Surgery · 88d
Cleared Aug 31, 1992
OPTHALMIC FRAMES
K922687 · HQZ
Optique Forte , Ltd.
Ophthalmic · 89d
Cleared Aug 28, 1992
AWOS ANGIOGRAPHIC WORKSTATION
K922804 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 28, 1992
ABL50 BLOOD GAS SYSTEM
K922922 · CHL
Radiometer America, Inc.
Chemistry · 72d
Cleared Aug 28, 1992
NEURAY SURGICAL PATTIES AND STRIPS
K923027 · HBA
Martland Healthcare, Inc.
Neurology · 66d
Cleared Aug 27, 1992
ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102
K905434 · DZE
Nobelpharma USA, Inc.
Dental · 632d
Cleared Aug 27, 1992
FISSURE SEALER
K913853 · EBC
Ortho Source
Dental · 366d
Cleared Aug 27, 1992
AP-6CR CINERADIOGRAPHIC FILM PROCESSOR
K915365 · IXX
The Allen Products Co.
Radiology · 274d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · BTO
Trinity Laboratories, Inc.
Anesthesiology · 218d
Cleared Aug 27, 1992
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · CCL
Puritan Bennett Corp.
Anesthesiology · 216d
Cleared Aug 27, 1992
TRACHEOSTOMY CARE KIT
K921281 · BTO
Trinity Laboratories, Inc.
Anesthesiology · 163d
Cleared Aug 27, 1992
SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R
K921425 · IZL
Acoma Medical Imaging, Inc.
Radiology · 156d
Cleared Aug 27, 1992
RUBELLA IGM
K921573 · LFX
Clark Laboratories, Inc.
Microbiology · 147d
Cleared Aug 27, 1992
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE
K922991 · LGS
Abbott Laboratories
Toxicology · 66d
Cleared Aug 27, 1992
MONAD NUCLEAR IMAGING SYSTEM
K923044 · KPS
Trionix Research Laboratory, Inc.
Radiology · 64d
Cleared Aug 27, 1992
GLENROE GOLDEN ORTHODONTIC BRACKET
K923124 · EJF
Glenroe
Dental · 62d
Cleared Aug 27, 1992
SILON TRANSPARENT WOUND DRESSINGS
K923150 · MGP
Bio Med Sciences, Inc.
General & Plastic Surgery · 59d
Cleared Aug 27, 1992
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL
K923202 · ELW
Jeneric/Pentron, Inc.
Dental · 58d
Cleared Aug 26, 1992
ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED
K912364 · ITX
Hitachi Medical Corp. of America
Radiology · 455d
Cleared Aug 26, 1992
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · KWP
Kirschner Medical Corp.
Orthopedic · 427d