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
39361–39384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2013
WMT IMPLANTABLE K-WIRE
K132895 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2013
MEDCOMP VASCU-PICC WITH VALVE
K130897 · LJS
Medcomp ( Medical Components)
General Hospital · 204d
Cleared Oct 22, 2013
RANFAC BONE MARROW ASPIRATION NEEDLE
K131157 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 181d
Cleared Oct 22, 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187 · KWD
Solana Surgical, LLC
Orthopedic · 179d
Cleared Oct 22, 2013
PERIFLUX 6000
K131253 · LKD
Perimed AB
Anesthesiology · 173d
Cleared Oct 22, 2013
TAUTONA INJECTOR DEVICE
K131963 · FMF
Tautona Group, LLC
General Hospital · 117d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 22, 2013
VISCOELASTIC INJECTOR
K132494 · MRH
Sight Sciences, Inc.
Ophthalmic · 74d
Cleared Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4...
K132673 · DQY
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 22, 2013
GEM FLOW COUPLER DEVICE AND SYSTEM
K132727 · MVR
Synovis Life Technologies, Inc.
General & Plastic Surgery · 49d
Cleared Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
K132751 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 49d
Cleared Oct 22, 2013
OCCLUSION BALLOON CATHETER
K132990 · MJN
Boston Scientific Corp
Cardiovascular · 28d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 21, 2013
NEO DENTA ZIRCONIA
K130198 · EIH
Neo Group Limited
Dental · 266d
Cleared Oct 21, 2013
BIOPLEX 2200 APLS IGM
K130528 · MID
Bio-Rad Laboratories
Immunology · 234d
Cleared Oct 21, 2013
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · LIO
Puritan Medical Products, LLC
Microbiology · 139d
Cleared Oct 21, 2013
SWIFT AIR
K132013 · BZD
Resmed, Ltd.
Anesthesiology · 112d
Cleared Oct 21, 2013
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
K132181 · EZN
Olympus Surgical Technologies America
Gastroenterology & Urology · 98d
Cleared Oct 18, 2013
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
K122437 · MBI
Biomet Sports Medicine
Orthopedic · 434d
Cleared Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
K122848 · MSS
Lenstec, Inc.
Ophthalmic · 395d
Cleared Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF...
K130213 · LDJ
Lumiquick Diagnostics, Inc.
Chemistry · 262d
Cleared Oct 18, 2013
ASA ORAL APPLIANCES
K130504 · LRK
American Sleep Association
Dental · 233d
Cleared Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684 · MKJ
Philips Medical Systems
Cardiovascular · 219d
Cleared Oct 18, 2013
CRANIAL MAP NEURO
K131214 · HAW
Stryker Corporate
Neurology · 172d