FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9625–9648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2023
ARGUS PB-3000
K221056 · MHX
Schiller AG
Cardiovascular · 451d
Cleared Jul 05, 2023
Rotium Bioresorbable Wick
K231641 · MAI
Nanofiber Solutions, LLC
Orthopedic · 30d
Cleared Jul 05, 2023
Universal Seal (5-12 mm)
K231358 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 56d
Cleared Jul 05, 2023
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter...
K231279 · KRA
Ablative Solutions, Inc.
Cardiovascular · 63d
Cleared Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...
K230864 · LON
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 05, 2023
Electric Scooter (Model: M2020)
K230001 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 183d
Cleared Jul 05, 2023
Integral Titanium Cervical Interbody
K222015 · ODP
Nvision Biomedical Technologies, Inc.
Orthopedic · 362d
Cleared Jul 05, 2023
LungTrainer (MD2 & MD3)
K221058 · BWF
Lung Trainers, LLC
Anesthesiology · 450d
Cleared Jul 05, 2023
Tissue Approximation System (TAS)
K220980 · GAR
Tas Medical, Inc.
General & Plastic Surgery · 457d
Cleared Jul 04, 2023
MemorialTM Gloves
K231740 · LZA
Us Glove Supply
General Hospital · 20d
Cleared Jul 03, 2023
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
K231653 · QEY
Thrombolex, Inc.
Cardiovascular · 27d
Cleared Jul 03, 2023
CarboClear® X Pedicle Screw System
K231280 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 61d
Cleared Jul 03, 2023
Premier HpSA Flex (619096)
K230901 · LYR
Meridian Bioscience, Inc.
Microbiology · 94d
Cleared Jul 03, 2023
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
K230720 · OLP
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 109d
Cleared Jul 03, 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · FXX
Cardinalhealth
General Hospital · 124d
Cleared Jul 03, 2023
Dental Lithium Disilicate Glass-Ceramic
K230487 · EIH
Fuzhou Rick Brown Biomaterials Co., Ltd.
Dental · 130d
Cleared Jul 03, 2023
IVYLASER Handhold Hair Removal Machine
K230025 · OHT
Ivylaser (Beijing) Technology Co.,Ltd
General & Plastic Surgery · 180d
Cleared Jul 03, 2023
Axial3D Insight
K222745 · QIH
Axial Medical Printing Limited
Radiology · 294d
Cleared Jul 03, 2023
CLEARinse CTS Specimen Collection and Transport System
K221664 · QBD
Aardvark Medical, Inc.
Microbiology · 390d
Cleared Jul 01, 2023
NB Implant System
K230725 · DZE
Arum Dentistry Co., Ltd.
Dental · 107d
Cleared Jun 30, 2023
iFuse TORQ® Implant System
K231689 · OUR
SI-BONE, Inc.
Orthopedic · 21d
Cleared Jun 30, 2023
IOB Temperature Management System
K231596 · DWJ
Iob Medical, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · OWQ
Abbott Medical
Cardiovascular · 29d
Cleared Jun 30, 2023
Vantage PSI System
K231585 · OYK
3D Systems, Inc.
Orthopedic · 30d