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
42985–43008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2012
3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM)...
K121484 · FRC
3M Company
General Hospital · 154d
Cleared Oct 19, 2012
ZFX DENTAL CAD SYSTEM
K121709 · NHA
Zimmer Dental, Inc.
Dental · 130d
Cleared Oct 19, 2012
SDX SYSTEM
K121845 · IYE
Dyn'R Sas
Radiology · 116d
Cleared Oct 19, 2012
VERTECEM II CEMENT KIT
K121876 · NDN
Aap Biomaterials GmbH
Orthopedic · 114d
Cleared Oct 19, 2012
NONDISPOSABLE STIMULATING INSTRUMENTS
K121931 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 19, 2012
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
K121962 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 106d
Cleared Oct 19, 2012
ZIRPRIME
K121980 · EIH
Kuraray Noritake Dental, Inc.
Dental · 105d
Cleared Oct 19, 2012
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · HSB
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 19, 2012
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
K122173 · MQB
Rayence Co., Ltd.
Radiology · 88d
Cleared Oct 19, 2012
VERSAFITCUP CC TRIO EXTENSION
K122911 · LZO
Medacta International
Orthopedic · 28d
Cleared Oct 19, 2012
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
K122913 · DWF
Medtronic, Inc.
Cardiovascular · 28d
Cleared CT Oct 19, 2012
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM...
K122916 · MCW
Medrad, Inc.
Cardiovascular · 28d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · FMI
Nipro Medical Corporation
General Hospital · 331d
Cleared Oct 18, 2012
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
K113471 · FPA
Nipro Medical Corporation
General Hospital · 331d
Cleared Oct 18, 2012
IPS E.MAX PRESS - ABUTMENT SOLUTIONS
K120053 · NHA
Ivoclar Vivadent, AG
Dental · 286d
Cleared Oct 18, 2012
STERILE BLUNT FOR SINGLE USE
K120420 · FMI
Shanghai Double Dove Industrial Co.,...
General Hospital · 251d
Cleared Oct 18, 2012
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
K121741 · ODP
4-Web, Inc.
Orthopedic · 127d
Cleared Oct 18, 2012
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER...
K121849 · DWM
Care Fusion
Anesthesiology · 115d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...
K121861 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 114d
Cleared Oct 18, 2012
DOMAIN SURGICAL SYSTEM
K121881 · HGI
Domain Surgical, Inc.
Obstetrics & Gynecology · 114d
Cleared Oct 18, 2012
AIRCAST VENAFLOW ELITE SYSTEM
K122499 · JOW
Djo, LLC
Cardiovascular · 63d
Cleared Oct 18, 2012
NMI HPICC III
K122882 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Oct 18, 2012
COUGAR LS 15 LATERAL CAGE SYSTEM
K122896 · MAX
Medos International SARL
Orthopedic · 27d
Cleared Oct 17, 2012
NIPRO SAFE TOUCH HUBER INFUSION SET
K113470 · FPA
Nipro Medical Corporation
General Hospital · 330d