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
42625–42648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2012
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND...
K123278 · KLE
Heraeus Kulzer, LLC
Dental · 46d
Cleared Dec 07, 2012
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K123446 · DXN
United States Gtm Medical Devices, Inc.
Cardiovascular · 29d
Cleared Dec 07, 2012
OCELOT CATHETER
K123462 · PDU
Avinger, Inc.
Cardiovascular · 28d
Cleared Dec 06, 2012
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
K112079 · BZD
Apex Medical Corp.
Anesthesiology · 504d
Cleared Dec 06, 2012
QT GUARD PLUS ANALYSIS SYSTEM
K120770 · DPS
Ge Medical Systems Information...
Cardiovascular · 267d
Cleared Dec 06, 2012
IMPLANT BAR
K120858 · NHA
Prismatik Dentalcraft, Inc.
Dental · 260d
Cleared Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR...
K121067 · PHX
Exactech, Inc.
Orthopedic · 244d
Cleared Dec 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
K121341 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 217d
Cleared Dec 06, 2012
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
K121382 · CAH
Westmed, Inc.
General Hospital · 212d
Cleared Dec 06, 2012
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
K121440 · ORY
Siesta Medical, Inc.
Dental · 205d
Cleared Dec 06, 2012
MRJ 3300
K122034 · LNH
Paramed S.R.L.
Radiology · 148d
Cleared Dec 06, 2012
PATRIOT SPACERS
K122097 · MAX
Globus Medical, Inc.
Orthopedic · 143d
Cleared Dec 06, 2012
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C...
K122101 · LCP
Sebia
Chemistry · 143d
Cleared Dec 06, 2012
PIEZOSURGERY TOUCH
K122322 · DZI
Mectron S.P.A.
Dental · 127d
Cleared Dec 06, 2012
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Dec 06, 2012
COMFORT EZ
K122787 · FMF
Simple Diagnostics, Inc.
General Hospital · 86d
Cleared Dec 06, 2012
PHYSIOSTAR NFC
K122852 · ELM
Candulor USA, Inc.
Dental · 79d
Cleared Dec 05, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
K121640 · JWH
Materialise NV
Orthopedic · 184d
Cleared Dec 05, 2012
CLARITY
K121663 · IYE
Elekta , Ltd.
Radiology · 183d
Cleared Dec 05, 2012
MERIT ONE SNARE SYSTEM
K122088 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
K122242 · JJX
Roche Diagnostics
Immunology · 131d
Cleared CT Dec 05, 2012
IGROW II HAIR GROWTH SYSTEM
K122248 · OAP
Apira Science, Inc.
General & Plastic Surgery · 131d
Cleared Dec 05, 2012
PKS BILL
K122605 · HIN
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 05, 2012
IN:C2 SPINAL FIXATION SYSTEM
K122630 · OVE
Spine Smith Partners L.P.
Orthopedic · 99d