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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46969–46992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2011
GE DATEX-OHMEDA AISYS
K110213 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 176d
Cleared Jul 20, 2011
OPTIMA CT660
K110227 · JAK
Ge Medical Systems, LLC
Radiology · 176d
Cleared Jul 20, 2011
SEVOFLURANE VAPORIZER ADAPTOR
K110608 · CAD
Piramal Critcal Care, Inc (Formerly...
Anesthesiology · 139d
Cleared Jul 20, 2011
COMMUNIFY PACS VIEWER
K110797 · LLZ
Flying Squirrel Storage, LLC
Radiology · 120d
Cleared Jul 20, 2011
STERI-DENT, STERI-SURE
K110867 · FRG
Cpac, Inc.
General Hospital · 113d
Cleared Jul 20, 2011
PATIENT MONITOR
K110922 · MHX
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared Jul 20, 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · PHX
Encore Medical, L.P.
Orthopedic · 93d
Cleared Jul 20, 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 82d
Cleared Jul 20, 2011
AIDITE ZIRCONIA DENTAL CERAMICS
K111291 · EIH
Qinhuangdao Aidite High-Technical...
Dental · 75d
Cleared Jul 20, 2011
AXXENT RADIATION SHIELD - RIGID
K111299 · JAD
Xoft, an Icad Company
Radiology · 72d
Cleared Jul 20, 2011
AAP CANNULATED SCREWS
K111316 · HWC
Aap Implantate AG
Orthopedic · 71d
Cleared Jul 20, 2011
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED...
K111399 · MBI
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 20, 2011
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
K111598 · LYZ
Lpl (Hui Zhou) Glove Co., Ltd.
General Hospital · 42d
Cleared Jul 20, 2011
PATHWAY MODEL 07XXXX
K111774 · MAX
Custom Spine
Orthopedic · 27d
Cleared Jul 19, 2011
BEL-CAT
K101181 · OAS
Takara Belmont Corp.
Radiology · 448d
Cleared Jul 19, 2011
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
K101407 · MIZ
Immuno-Mycologics, Inc.
Microbiology · 426d
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129 · GWQ
Ge Healthcare
Neurology · 270d
Cleared Jul 19, 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 215d
Cleared Jul 19, 2011
BD INSYTE AUTOGUARD BC
K110443 · FOZ
Becton, Dickinson & CO
General Hospital · 153d
Cleared Jul 19, 2011
MINI TELEMETRY SYSTEM
K110556 · HGM
Wipro GE Healthcare Private, Ltd.
Obstetrics & Gynecology · 141d
Cleared Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · HIG
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 113d
Cleared Jul 19, 2011
MEDLINE VESSEL CANNULA
K111147 · DWF
Medline Industries, Inc.
Cardiovascular · 85d
Cleared Jul 19, 2011
OPTIMA XR120
K111304 · IXL
Ge Medical Systems, LLC
Radiology · 71d
Cleared Jul 19, 2011
NEURON MAX SYSTEM
K111380 · DQY
Penumbra, Inc.
Cardiovascular · 64d