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
39409–39432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
K132438 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 73d
Cleared Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
K132468 · NQX
Elitechgroup Epoch Biosciences
Microbiology · 71d
Cleared Oct 17, 2013
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE +...
K132612 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared Oct 17, 2013
DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
K132636 · LLZ
Smith & Nephew, Inc.
Radiology · 56d
Cleared Oct 17, 2013
SITE-RITE VISION II ULTRASOUND SYSTEM
K132942 · IYN
C.R. Bard, Inc.
Radiology · 28d
Cleared Oct 16, 2013
MEDLINE SUCTION COAGULATOR
K122949 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 387d
Cleared Oct 16, 2013
PROW FUSION
K130254 · MAX
Nlt Spine, Ltd.
Orthopedic · 257d
Cleared Oct 16, 2013
BRAEMAR CARDIOKEY HOLTER RECORDER
K130294 · MWJ
Braemar Manufacturing, LLC
Cardiovascular · 252d
Cleared Oct 16, 2013
PEDIATRIC FOLDING WHEELCHAIR
K130644 · LBE
Columbia Medical Mfg, LLC
Physical Medicine · 219d
Cleared Oct 16, 2013
NASAL COMFORT FREEDOM
K130686 · BZD
Lakeview Sleep Center
Anesthesiology · 217d
Cleared Oct 16, 2013
OVATION 10/12 HIP STEM
K131022 · LPH
Ortho Development Corp.
Orthopedic · 187d
Cleared Oct 16, 2013
FINGERTIP PULSE OXIMETER
K131047 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 184d
Cleared Oct 16, 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K131231 · PHX
Tornier S.A.S.
Orthopedic · 169d
Cleared Oct 16, 2013
IFUSE IMPLANT SYSTEM
K131405 · OUR
SI-BONE, Inc.
Orthopedic · 154d
Cleared Oct 16, 2013
SMOOTH OR THREADED METALLIC BONE FASTENER
K131640 · HTY
Biomedical Ent., Inc.
Orthopedic · 134d
Cleared Oct 16, 2013
VANTAGE TITAN 3T
K132160 · LNH
Toshibamedical Systems Corporation
Radiology · 96d
Cleared Oct 16, 2013
.DECIMAL PROTON APERTURE
K132236 · IXI
.Decimal, Inc.
Radiology · 90d
Cleared Oct 16, 2013
A.I.M. SUTURE ANCHOR
K132461 · MBI
Anchor Innovation Medical, Inc.
Orthopedic · 70d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 15, 2013
NON-CONTACT INFRARED THERMOMETER
K130231 · FLL
Jinxinbao Electronic Co.,Ltd
General Hospital · 259d
Cleared Oct 15, 2013
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K131234 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 167d
Cleared Oct 15, 2013
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · KGE
Endochoice, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 15, 2013
MULTICHEM U
K131993 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 109d
Cleared Oct 11, 2013
BASIC AND DOMINANT FLEX SUCTION PUMPS
K130123 · BTA
Medela AG
General & Plastic Surgery · 267d