FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39265–39288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Nov 01, 2013
RAYSCAN A-EXPERT
K131693 · MUH
Ray Co., Ltd.
Radiology · 144d
Cleared Nov 01, 2013
RAYSCAN A-EXPERT 3D
K131695 · OAS
Ray Co., Ltd.
Radiology · 144d
Cleared Nov 01, 2013
ENAMELAST
K132109 · LBH
Ultradent Products Inc. / Oratech, LLC
Dental · 116d
Cleared Nov 01, 2013
KLARITY VACUUM BAG, KLARITY MOLD CUSHION
K132124 · IYE
Klarity Medical Products, LLC
Radiology · 114d
Cleared Nov 01, 2013
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL...
K132450 · KLE
Kuraray Noritake Dental, Inc.
Dental · 87d
Cleared Nov 01, 2013
QUIET/SILENT SCANNING SUITE
K132831 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Nov 01, 2013
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
K132883 · HRX
Hemodia Sas
Orthopedic · 49d
Cleared Oct 31, 2013
INVOTEC LARYNGEAL ELECTRODE
K122040 · ETN
Invotec International, Inc.
Ear, Nose, Throat · 476d
Cleared Oct 31, 2013
LUNA DENTAL IMPLANT SYSTEM
K123155 · DZE
Shinhung Mst Co., Ltd.
Dental · 387d
Cleared Oct 31, 2013
FIRMAP CATHETER
K130827 · MTD
Topera, Inc.
Cardiovascular · 219d
Cleared Oct 31, 2013
AMPCARE ESP THERAPY SYSTEM
K131222 · IPF
Ampcare, LLC
Physical Medicine · 184d
Cleared Oct 31, 2013
OSSEOFUSE DENTAL IMPLANT SYSTEM
K131748 · DZE
Osseofuse, Inc.
Dental · 139d
Cleared Oct 31, 2013
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE...
K131894 · GEX
Nidek Co., Ltd.
General & Plastic Surgery · 128d
Cleared Oct 31, 2013
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · PDU
Boston Scientific Corp
Cardiovascular · 127d
Cleared Oct 31, 2013
GSB GLOBAL SPINAL BALANCE SYSTEM
K132014 · NKB
Nuvasive, Inc.
Orthopedic · 122d
Cleared Oct 31, 2013
IPS E.MAX CAD ABUTMENT SOLUTIONS
K132209 · NHA
Ivoclar Vivadent, AG
Dental · 107d
Cleared Oct 31, 2013
ALTUS SPINE PEDICLE SCREW SYSTEM
K132280 · MNI
Altus Partners
Orthopedic · 100d
Cleared Oct 31, 2013
PAXERAPACS
K132586 · LLZ
Paxeramed
Radiology · 76d
Cleared Oct 31, 2013
UNIQUE
K132705 · IYE
Varian Medical Systems, Inc.
Radiology · 63d
Cleared Oct 31, 2013
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · DTE
Medtronic, Inc.
Cardiovascular · 43d
Cleared Oct 31, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING...
K132995 · DWF
Medtronic, Inc.
Cardiovascular · 37d
Cleared Oct 30, 2013
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
K122783 · OQG
Aesculap Implant System, Inc.
Orthopedic · 414d
Cleared Oct 30, 2013
DIPLOMAT
K130534 · EIA
Diplomat Dental S.R.O.
Dental · 243d