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
40873–40896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2013
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
K130489 · FEH
Optim, LLC
Gastroenterology & Urology · 53d
Cleared Apr 18, 2013
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
K121659 · PDT
Arcos, Inc.
General & Plastic Surgery · 317d
Cleared Apr 18, 2013
PREXION3D ECLIPSE
K122199 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 268d
Cleared Apr 18, 2013
A3F FRATIONAL
K122200 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 267d
Cleared Apr 18, 2013
RHYTHMIA MAPPING CATHETER
K122461 · DRF
Rhythmia Medical, Inc.
Cardiovascular · 248d
Cleared Apr 18, 2013
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
K123280 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 178d
Cleared Apr 18, 2013
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
K123676 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 139d
Cleared Apr 18, 2013
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900 · MHX
Philips Medical Systems
Cardiovascular · 121d
Cleared Apr 18, 2013
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
K124049 · DPT
Spectralmd, Inc.
Cardiovascular · 108d
Cleared Apr 18, 2013
COMINED STANDARD SOLUTION
K130100 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 93d
Cleared Apr 18, 2013
HYDRASOLVE LIPOPLASTY SYSTEM
K130152 · MUU
Andrew Technologies, LLC
General & Plastic Surgery · 86d
Cleared Apr 18, 2013
EPICAGE INTERBODY FUSION DEVICE
K130548 · MAX
Alphatec Spine, Inc.
Orthopedic · 45d
Cleared Apr 18, 2013
ENDO GIA RELOAD
K130717 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 34d
Cleared Apr 18, 2013
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130770 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130772 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883 · MQB
Sedecal., Sa.
Radiology · 20d
Cleared Apr 17, 2013
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
K121770 · CAF
Headstar Medical Products Co., Ltd.
Anesthesiology · 306d
Cleared Apr 17, 2013
PLASMATRODE SALINE SAFE TUR ELECTRODE
K122716 · GEI
Cook Ireland, Ltd.
General & Plastic Surgery · 224d
Cleared Apr 17, 2013
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · DWJ
Covidien
Cardiovascular · 198d
Cleared Apr 17, 2013
M300 & M400
K123290 · ITI
Permobil AB
Physical Medicine · 177d
Cleared Apr 17, 2013
VS3
K123467 · GCJ
Visionsense, Ltd.
General & Plastic Surgery · 159d
Cleared Apr 17, 2013
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH...
K123593 · LKP
Inova Diagnostics, Inc.
Immunology · 147d
Cleared Apr 17, 2013
TRUECPR COACHING DEVICE
K123597 · LIX
Physio-Control, Inc.
Cardiovascular · 147d
Cleared Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804 · KNT
Hollister, Inc.
Gastroenterology & Urology · 128d