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

Filters: Cleared only ×
175,820 results
52609–52632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2009
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
K091648 · GCJ
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 57d
Cleared Aug 05, 2009
BIPAP SYNCHRONY 2
K092043 · MNS
Respironics, Inc.
Anesthesiology · 30d
Cleared Aug 05, 2009
OPTILOCK PERIARTICULAR PLATING
K092078 · HRS
Biomet Trauma
Orthopedic · 27d
Cleared Aug 04, 2009
EZC MEDICAL, LLC INTUBAIDFLEX
K090777 · BTR
Ezc Medical, LLC
Anesthesiology · 134d
Cleared Aug 04, 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · DTN
Gish Biomedical, Inc.
Cardiovascular · 112d
Cleared Aug 04, 2009
RESTORELLE POLYPROPYLENE MESH
K092207 · OTP
Mpathy Medical Devices, Inc.
Obstetrics & Gynecology · 13d
Cleared Aug 03, 2009
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K083097 · MLR
STERIS Corporation
General Hospital · 290d
Cleared Aug 03, 2009
LIFECARE ELECTRODES
K083302 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 266d
Cleared Aug 03, 2009
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · HRX
Arthrex, Inc.
Orthopedic · 231d
Cleared Aug 03, 2009
QUATTRO LT
K091129 · BZD
Resmed, Ltd.
Anesthesiology · 105d
Cleared Aug 03, 2009
REMSTAR AUTO A-FLEX
K091319 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 90d
Cleared Aug 03, 2009
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
K091333 · MRR
Alfa Wassermann, Inc.
Chemistry · 89d
Cleared Aug 03, 2009
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321,...
K091659 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 55d
Cleared Aug 03, 2009
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM,...
K091768 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 03, 2009
MODIFICATION TO: DSS STABILIZATION SYSTEM
K091944 · NQP
Paradigm Spine, LLC
Orthopedic · 34d
Cleared Jul 31, 2009
TI-TAMED SPINAL SYSTEM
K070385 · NKB
Ti-Tamed (Pty), Ltd.
Orthopedic · 903d
Cleared Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 270d
Cleared Jul 31, 2009
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH...
K083408 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 255d
Cleared Jul 31, 2009
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH...
K083410 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 255d
Cleared Jul 31, 2009
PASS LP SPINAL SYSTEM
K083810 · MNI
Medicrea Technologies
Orthopedic · 221d
Cleared Jul 31, 2009
CHESSON LABS LIQUID BANDAGE
K083913 · KMF
Chesson Laboratory Associates, Inc.
General & Plastic Surgery · 213d
Cleared Jul 31, 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949 · HWC
Synthes (Usa)
Orthopedic · 119d
Cleared Jul 31, 2009
BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
K090967 · GKZ
Bd Biosciences
Hematology · 116d
Cleared Jul 31, 2009
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
K091178 · MMP
Mtp Medical Technical Promotion GmbH
General Hospital · 100d