Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
69913–69936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2004
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
K031935 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 254d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · DRT
Shenzhen Mindray Bio-Medical...
Cardiovascular · 181d
Cleared Mar 03, 2004
ATRION MEDICAL QL INFLATION DEVICE
K032840 · KOE
Atrion Medical Products, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 03, 2004
POWDERED LATEX EXAMINATION GLOVES
K033531 · LYY
Apl International Incorporated Limited
General Hospital · 114d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 70d
Cleared Mar 03, 2004
B.BRAUN PREMIXED DIALYSATE
K034066 · KPO
B.Braun Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K040037 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Mar 03, 2004
NDX-40 ALLOY
K040043 · EJT
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Mar 03, 2004
CONTINUM
K040179 · EJH
Aalba Dent, Inc.
Dental · 36d
Cleared Mar 03, 2004
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
K040210 · DTZ
Terumo Corp.
Cardiovascular · 33d
Cleared Mar 03, 2004
PLUME SAFETY AVF NEEDLE
K040247 · FIE
Jms North America Corp.
Gastroenterology & Urology · 29d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · ERL
Stryker Instruments
Ear, Nose, Throat · 23d
Cleared Mar 03, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A...
K040357 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 19d
Cleared Mar 02, 2004
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III...
K023342 · KOI
Hdc Corp.
Anesthesiology · 512d
Cleared Mar 02, 2004
CT OIA
K032330 · LJC
Thermo Biostar, Inc.
Microbiology · 217d
Cleared Mar 02, 2004
THE FRIENDLYLIGHT ND: YAG LASERS
K033251 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 147d
Cleared Mar 02, 2004
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
K033555 · ILY
Kaylight Corporation
Physical Medicine · 111d
Cleared Mar 02, 2004
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
K033619 · HAW
Image-Guided Neurologics, Inc.
Neurology · 105d
Cleared Mar 02, 2004
CT-MASS
K033774 · JAK
Medis Medical Imaging Systems BV
Radiology · 90d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · JDQ
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 02, 2004
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K),...
K033851 · JIL
Hypoguard USA, Inc.
Chemistry · 82d
Cleared Mar 02, 2004
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
K033881 · DXT
Medrad, Inc.
Cardiovascular · 78d
Cleared Mar 02, 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE...
K033887 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 78d