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
58729–58752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2007
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK
K070895 · JOJ
STERIS Corporation
General Hospital · 159d
Cleared Sep 05, 2007
ALPHAONE BIOFEEDBACK SYSTEM
K071661 · HCC
Telediagnostic Systems, Inc.
Neurology · 78d
Cleared Sep 05, 2007
COMFY SERIES: EV-804, EV-805 & EV-806
K071951 · GZJ
Everyway Medical Instruments Co.,Ltd
Neurology · 51d
Cleared Sep 05, 2007
1.5T MRGFUS PELVIC COIL
K071966 · MOS
Insightec Txsonics, Inc.
Radiology · 51d
Cleared Sep 05, 2007
NEXGEN TRABECULAR METAL TIBIAL TRAY
K072160 · MBH
Zimmer, Inc.
Orthopedic · 30d
Cleared Sep 05, 2007
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
K072164 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 30d
Cleared Sep 05, 2007
ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
K072177 · GEI
Surgrx, Inc.
General & Plastic Surgery · 30d
Cleared Sep 05, 2007
ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
K072183 · NKB
Zimmer Spine, Inc.
Orthopedic · 30d
Cleared Sep 04, 2007
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY...
K070531 · CGZ
Thermo Fisher Scientific
Chemistry · 193d
Cleared Sep 04, 2007
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K071016 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 147d
Cleared Sep 04, 2007
DANA 3CC SYRINGE INSULIN RESERVOIR
K071418 · MRZ
Sooil Development Co., Ltd.
General Hospital · 105d
Cleared Sep 04, 2007
OSTEOGRAF/N-300
K071817 · LYC
Dentsply Interntional
Dental · 63d
Cleared Sep 04, 2007
ACME TALON PEDICLE SCREW
K071824 · MNI
Acme Spine, LLC
Orthopedic · 63d
Cleared Sep 04, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072085 · LYZ
Zibo Hongye Shangqin Plastic Rubbert...
General Hospital · 36d
Cleared Aug 31, 2007
OPACIDEN OPA REAGENT STRIPS
K070419 · JOJ
Hach Company
General Hospital · 199d
Cleared Aug 31, 2007
STRAUMANN P.004 RC GOLD ABUTMENT
K070549 · NHA
Institut Straumann AG
Dental · 186d
Cleared Aug 31, 2007
PHARMAPAC LUBRICATING JELLY
K070623 · NUC
Pharmapac, LLC
Obstetrics & Gynecology · 178d
Cleared Aug 31, 2007
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION...
K070630 · FPA
Health Line International Corporation...
General Hospital · 177d
Cleared Aug 31, 2007
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
K070754 · MQP
Zimmer Trabecular Metal Technology
Orthopedic · 165d
Cleared Aug 31, 2007
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K070795 · DSK
Atcor Medical Pty, Ltd.
Cardiovascular · 162d
Cleared Aug 31, 2007
ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL...
K071080 · GEI
E Surgical, LLC
General & Plastic Surgery · 136d
Cleared Aug 31, 2007
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
K071167 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 127d
Cleared Aug 31, 2007
THE PORTABLE ANSISCOPE
K071168 · DPS
Dyansys, Inc.
Cardiovascular · 126d
Cleared Aug 31, 2007
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
K071225 · DXC
Innovasa, Inc.
Cardiovascular · 121d