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
133249–133272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1989
ALTA NON-REAMED TIBIAL ROD
K884500 · HSB
Howmedica Corp.
Orthopedic · 84d
Cleared Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · DQO
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Jan 18, 1989
BTE HEARING AID SIEMENS MODEL 284PP-ASP
K884583 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 18, 1989
EXEL 1800 AND 1800E CT SCANNER
K884670 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
EXEL 2400 AND 2400 ELITE CT SCANNERS
K884671 · JAK
Elscint, Inc.
Radiology · 71d
Cleared Jan 18, 1989
NON-STERILE VINYL GLOVES
K885346 · FMC
Daw Shin Industrial Co., Ltd.
General Hospital · 21d
Cleared Jan 17, 1989
CURIETRON 192 LOW DOSE RATE
K881323 · JAQ
Compagnie Oris Industrie, S.A.
Radiology · 295d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
K882824 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
K882825 · DXN
A&D Engineering, Inc.
Cardiovascular · 193d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069 · DRT
Kontron Instruments, Inc.
Cardiovascular · 181d
Cleared Jan 17, 1989
MINIMON 7136B PATIENT MONITOR
K883109 · DRT
Kontron, Inc.
Cardiovascular · 176d
Cleared Jan 17, 1989
THORACIC SUPPORT SYSTEM
K883214 · KMO
Storer Medical Products
General Hospital · 172d
Cleared Jan 17, 1989
EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
K883402 · DPS
Quinton, Inc.
Cardiovascular · 166d
Cleared Jan 17, 1989
E550 ELECTROCARDIOGRAPH
K883440 · DSI
Burdick Corp.
Cardiovascular · 155d
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · DTB
Medtronic Vascular
Cardiovascular · 138d
Cleared Jan 17, 1989
DM100 (DISTAL MONITOR - 100)
K884135 · HCC
Bio.Logic, Inc.
Neurology · 109d
Cleared Jan 17, 1989
THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
K884158 · CCK
Ppg Industries, Inc.
Anesthesiology · 105d
Cleared Jan 17, 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
K884398 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Jan 17, 1989
TECNOL VARIABLE TENSION BANDAGE
K884440 · NAD
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 88d
Cleared Jan 17, 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 17, 1989
INTRODUCER SAFETY SYRINGE
K884490 · DQX
Arrow Intl., Inc.
Cardiovascular · 83d
Cleared Jan 17, 1989
SERVO VENTILATOR 900E
K884520 · CBK
Siemens-Elema Ventilation Systems
Anesthesiology · 82d
Cleared Jan 17, 1989
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
K884539 · DSI
Rmv Medical (Romavat, Inc.)
Cardiovascular · 81d
Cleared Jan 17, 1989
IMPULSE EPIDURAL ELECTRODE
K884663 · JXE
Impulse Systems, Inc.
Neurology · 71d