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
43969–43992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2012
DR GREENBURGS HYBRID ACRYLIC
K120371 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
DR GREENBURGS HYBRID VACUUM
K120372 · LRK
Always More Marketing, Inc.
Dental · 142d
Cleared Jun 27, 2012
LDR SPINE SPINETUNE TL SPINAL SYSTEM
K120760 · MNH
Ldr Spine USA, Inc.
Orthopedic · 106d
Cleared Jun 27, 2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
K120780 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 105d
Cleared Jun 27, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · MNH
K2m, Inc.
Orthopedic · 84d
Cleared Jun 27, 2012
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · KWQ
Globus Medical, Inc.
Orthopedic · 82d
Cleared Jun 27, 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K121211 · OVD
Theken Spine, LLC
Orthopedic · 68d
Cleared Jun 27, 2012
PIXEL APP
K121274 · LWH
Gauss Surgical, Inc.,
General & Plastic Surgery · 61d
Cleared Jun 27, 2012
ARTISTETM SOLUTION WITH SYS VCIO
K121295 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Jun 27, 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
K121522 · FRO
Polyremedy, Inc.
General & Plastic Surgery · 35d
Cleared Jun 26, 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
K111369 · CFF
Helena Laboratories Uk, Ltd.
Immunology · 407d
Cleared Jun 26, 2012
SYS*STIM 240
K113017 · IPF
Mettler Electronics Corp.
Physical Medicine · 259d
Cleared Jun 26, 2012
XTRAFIX EXTERNAL FIXATION SYSTEM
K113383 · KTT
Extraortho, Inc.
Orthopedic · 223d
Cleared Jun 26, 2012
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
K120002 · KNW
Busse Hospital Disposables, Inc.
Gastroenterology & Urology · 175d
Cleared Jun 26, 2012
SURGIMESH XB - SKIRTED
K120025 · FTL
Aspide Medical
General & Plastic Surgery · 175d
Cleared Jun 26, 2012
AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
K120632 · MLR
STERIS Corporation
General Hospital · 117d
Cleared Jun 26, 2012
ENSPIRE DISCECTOMY SYSTEM
K120680 · HRX
Spine View, Inc.
Orthopedic · 112d
Cleared Jun 26, 2012
GLIDER PTCA BALLOON CATHETER
K121681 · LOX
Trireme Medical, Inc.
Cardiovascular · 19d
Cleared Jun 25, 2012
IPS E.MAX PRESS MULTI
K120134 · EIH
Ivoclar Vivadent, AG
Dental · 160d
Cleared Jun 25, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE...
K120336 · LZC
Hartalega Sdn Bhd
General Hospital · 143d
Cleared Jun 25, 2012
AQUAMANTRYS3 BSC 9.1S
K121290 · GEI
Medtronic, Inc.
General & Plastic Surgery · 56d
Cleared Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · MSV
Phadia US, Inc.
Immunology · 305d
Cleared Jun 22, 2012
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · FRG
Kimberly-Clark Corp.
General Hospital · 269d
Cleared Jun 22, 2012
SHEATHES ULTRASOND GEL
K112827 · MUI
Sheathing Technologies, Inc.
Radiology · 268d