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
63289–63312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2006
SEMPERFLO INFUSION SYSTEM
K052999 · MEB
Ethicon, Inc.
General Hospital · 148d
Cleared Mar 22, 2006
HSINER RESUSCITATOR
K053466 · BTM
Hsiner Co., Ltd.
Anesthesiology · 99d
Cleared Mar 22, 2006
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
K060239 · ESW
Alveolus, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 22, 2006
DIAPHYSEAL PLATE
K060294 · HRS
Hand Innovations, LLC
Orthopedic · 44d
Cleared Mar 22, 2006
RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM
K060411 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 34d
Cleared Mar 22, 2006
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437 · MEH
Aesculap, Inc.
Orthopedic · 29d
Cleared Mar 22, 2006
M-VU VIEWER STATION
K060451 · LLZ
Vucomp, Inc.
Radiology · 29d
Cleared Mar 21, 2006
A.B. DENTAL DEVICES
K051719 · DZE
A.B. Dental Devices , Ltd.
Dental · 267d
Cleared Mar 21, 2006
EVERSTICK A&O
K051953 · DYW
Stick Tech , Ltd.
Dental · 246d
Cleared Mar 21, 2006
INQUIRY AFOCUS II DIAGNOSTIC CATHETER
K053582 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 88d
Cleared Mar 21, 2006
BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP...
K060121 · HAW
Biomet Manufacturing Corp
Neurology · 63d
Cleared Mar 21, 2006
APOLLO IR HEAT LAMP SYSTEM
K060134 · ILY
Apollo Physical Therapy Products...
Physical Medicine · 62d
Cleared Mar 21, 2006
AFT ALLOGRAFT FILLER TUBE
K060161 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 60d
Cleared Mar 21, 2006
MISSION COMPLETE
K060206 · JJY
Diamond Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 21, 2006
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
K060304 · GEX
Biotex, Inc.
General & Plastic Surgery · 43d
Cleared Mar 21, 2006
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC...
K060322 · JIT
Cliniqa Corporation
Chemistry · 40d
Cleared Mar 21, 2006
NORIAN SRS BONE VOID FILLER
K060408 · MQV
Synthes (Usa)
Orthopedic · 33d
Cleared Mar 21, 2006
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K060417 · DIF
Quantimetrix Corp.
Toxicology · 32d
Cleared Mar 20, 2006
KAVS - CATHETER, MODELS 1107100 & 1107060
K052844 · MJN
Richter & Rothe AG
Cardiovascular · 164d
Cleared Mar 20, 2006
FRAXEL SR LASER SYSTEM
K053047 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 143d
Cleared Mar 20, 2006
IR WIRELESS FOOT SWITCH
K053510 · GEI
Linemaster Switch Corp.
General & Plastic Surgery · 94d
Cleared Mar 20, 2006
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
K060156 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 59d
Cleared Mar 20, 2006
NORIAN SRS FAST SET PUTTY
K060406 · MQV
Synthes (Usa)
Orthopedic · 32d
Cleared Mar 20, 2006
MULTISTAR
K060455 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 26d