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
43081–43104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2012
SENTINEL
K120668 · IYE
C-Rad Positioning AB
Radiology · 147d
Cleared Jul 30, 2012
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
K121231 · NGT
Ind Ndiagnostic, Inc.
General Hospital · 97d
Cleared Jul 30, 2012
DYNAPBV BODY SOFTWARE
K121292 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 30, 2012
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
K121299 · NKB
Safe Orthopaedics
Orthopedic · 91d
Cleared Jul 30, 2012
XPRESSWAY RX CATHETER (6F LD-VERISON)
K121301 · QEZ
Kaneka Pharma America, LLC
Cardiovascular · 90d
Cleared Jul 30, 2012
HIP SYSTEMS
K121308 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 30, 2012
DYNASTY BIOFOAM SHELL
K121544 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
K121734 · DQO
Scientia Vascular, LLC
Cardiovascular · 47d
Cleared Jul 27, 2012
MULTIPLATE 5.0 AGGREGOMETER
K103555 · JOZ
Verum Diagnostica GmbH
Hematology · 602d
Cleared Jul 27, 2012
HC-BIOS DENTAL IMPLANT
K110425 · DZE
Hung Chun Bio-S Co., Ltd.
Dental · 529d
Cleared Jul 27, 2012
IO-TOME DEVICE
K113073 · HAE
Baxano, Inc.
Neurology · 284d
Cleared Jul 27, 2012
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
K113307 · LFR
Hmd Biomedical, Inc.
Chemistry · 262d
Cleared Jul 27, 2012
ORION
K113489 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 247d
Cleared Jul 27, 2012
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
K113544 · GZJ
Prospera Corporation
Neurology · 239d
Cleared Jul 27, 2012
EON CHOLESTEROL REAGENT
K120202 · CHH
Vital Diagnostics Pty., Ltd.
Chemistry · 186d
Cleared Jul 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE
K120230 · LYZ
Shandong Taixiang Medical Products...
General Hospital · 184d
Cleared Jul 27, 2012
MOJO, VERASEAL
K120463 · BZD
Sleepnet Corporation
Anesthesiology · 163d
Cleared Jul 27, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120797 · LYZ
Shandong Shouguang Kingliyuan Medical...
General Hospital · 134d
Cleared Jul 27, 2012
ENDOBEAM HOLMIUM LASER FIBERS
K120926 · GEX
C.R. Bard, Inc.
General & Plastic Surgery · 122d
Cleared Jul 27, 2012
ZEOBI
K121338 · ILX
Ivivi Health Science, LLC
Physical Medicine · 85d
Cleared Jul 27, 2012
IPS 99 ONE AND IPS 99 CERAM
K121359 · EIH
Ivoclar Vivadent, AG
Dental · 81d
Cleared Jul 27, 2012
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · ODP
Accel Spine
Orthopedic · 59d
Cleared Jul 27, 2012
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
K121604 · FER
Obp Corporation
Gastroenterology & Urology · 56d
Cleared Jul 27, 2012
SENSICARDIAC
K121617 · DQD
Diacoustic Medical (Pty)
Cardiovascular · 56d