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
20665–20688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2019
OMNI-STAT Vascular (Rapid)
K190012 · QSY
Medtrade Product, Ltd.
General & Plastic Surgery · 349d
Cleared Dec 18, 2019
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway...
K190824 · CCK
Bluepoint Medical GmbH & Co. KG
Anesthesiology · 261d
Cleared Dec 18, 2019
IntraMarX Radiopaque Markers
K191087 · FFX
Anx Robotica Corp
Gastroenterology & Urology · 238d
Cleared Dec 18, 2019
BioSticker System
K191614 · DRG
Biointellisense, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2019
Electronic Stethoscope
K191667 · DQD
Hefei Mintti Medical Technology Co.,...
Cardiovascular · 180d
Cleared Dec 18, 2019
Sterile Latex Powder-Free Surgical Gloves
K191898 · KGO
Modern Healthcare Corp.
General Hospital · 155d
Cleared Dec 18, 2019
Avenir Complete Hip System, Size 0 Coxa Vara
K192189 · LZO
Zimmer, Inc.
Orthopedic · 127d
Cleared Dec 18, 2019
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K192580 · GAM
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Dec 18, 2019
BEACON Caresystem Model 00002144
K192584 · BZK
Mermaid Care A/S
Anesthesiology · 90d
Cleared Dec 18, 2019
Neodent Instrument Kit Cases
K192670 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 84d
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