FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
21265–21288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2019
Percusys® Plus Pedicle Screw System
K192680 · NKB
Joimax GmbH
Orthopedic · 83d
Cleared Dec 17, 2019
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs...
K190725 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 272d
Cleared Dec 17, 2019
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K191758 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 169d
Cleared Dec 17, 2019
InMode System with Tone Applicator
K192249 · IPF
Inmode , Ltd.
Physical Medicine · 120d
Cleared Dec 17, 2019
ILUMIEN System with AptiVue Software version D.3
K192267 · DQO
Abbott Medical
Cardiovascular · 118d
Cleared Dec 17, 2019
Precision Casting Solutions Total Hip System
K192450 · LPH
Precision Casting Solution, LLC
Orthopedic · 102d
Cleared Dec 17, 2019
CNS Envision
K192572 · OLT
Moberg Research, Inc.
Neurology · 90d
Cleared Dec 17, 2019
ExSpiron 2Xi
K192595 · BZK
Respiratory Motion
Anesthesiology · 88d
Cleared Dec 17, 2019
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology...
K192615 · FTM
Synovis Life Technologies, Inc....
General & Plastic Surgery · 85d
Cleared Dec 17, 2019
syngo.CT CaScoring
K192763 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Dec 17, 2019
Single Use Balloon Dilator V (with knife)
K193039 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Dec 17, 2019
Bashir Plus Endovascular Catheter
K193071 · QEY
Thrombolex, Inc.
Cardiovascular · 43d
Cleared Dec 17, 2019
EV1000 Clinical Platform
K193179 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Dec 17, 2019
G Surgical Marksman System
K193219 · NKB
G Surgical, LLC
Orthopedic · 26d
Cleared Dec 16, 2019
Pantheon Spinal Pontus Interbody Fusion Device
K181548 · MAX
Pantheon Spinal
Orthopedic · 552d
Cleared Dec 16, 2019
SunClear Aligner system
K190394 · NXC
Sun Dental Laboratories, LLC
Dental · 300d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Dec 16, 2019
Llis, Vittra APS
K191306 · EBF
Dentscare Ltda
Dental · 216d
Cleared Dec 16, 2019
EM Provisional
K191751 · DZE
Hiossen, Inc.
Dental · 168d
Cleared Dec 16, 2019
Stand-Alone ALIF Titanium System
K191834 · OVD
Life Spine, Inc.
Orthopedic · 160d
Cleared Dec 16, 2019
Deka Luxea
K192539 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 91d
Cleared Dec 16, 2019
CORRIDOR Fixation System
K192744 · MRW
Globus Medical, Inc.
Orthopedic · 77d
Cleared Dec 16, 2019
Physio Flex Annuloplasty Ring
K192762 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 77d
Cleared Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
K192943 · DJG
Microgenics Corporation
Toxicology · 59d