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
10969–10992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
K221253 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 277d
Cleared Feb 03, 2023
IntelliVue Patient Monitor MX750 (866471)
K221348 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 270d
Cleared Feb 03, 2023
Anivia SG1000 Pump Console
K221491 · DWA
Apmtd, Inc.
Cardiovascular · 256d
Cleared Feb 03, 2023
MONTAGE Settable, Resorbable Bone Putty
K222063 · MQV
Orthocon, Inc.
Orthopedic · 205d
Cleared Feb 03, 2023
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular...
K222153 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 198d
Cleared Feb 03, 2023
AcuPebble OX100
K222950 · MNR
Acurable Limited
Anesthesiology · 129d
Cleared Feb 03, 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 127d
Cleared Feb 03, 2023
Pre-Formed Silicone Block
K223051 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 127d
Cleared Feb 03, 2023
Luna Dental Implant System
K223395 · NHA
Shinhung Mst Co., Ltd.
Dental · 87d
Cleared Feb 03, 2023
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
K223481 · LON
bioMerieux, Inc.
Microbiology · 77d
Cleared Feb 03, 2023
Cook® Spectrum® 2 MRC Central Venous Catheter
K223648 · FOZ
Cook Advanced Technologies
General Hospital · 59d
Cleared Feb 03, 2023
Access AMH
K223679 · PQO
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Feb 03, 2023
SMR Shoulder System
K223876 · MBF
Lima Corporate S.P.A.
Orthopedic · 42d
Cleared Feb 03, 2023
14F iSLEEVE™ Introducer Set
K230051 · DYB
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 03, 2023
Digital Flat Panel Detector
K230059 · MQB
Ray Imaging Technology (Haining) Limited
Radiology · 25d
Cleared Feb 02, 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · QSY
Bc3 Technologies, Inc.
General & Plastic Surgery · 692d
Cleared Feb 02, 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · FLE
Steelco S.P.A.
General Hospital · 451d
Cleared Feb 02, 2023
Geonic Nasal Aspirator, Geonic Nasal Cleaner
K220126 · BTA
Geon Corporation
Ear, Nose, Throat · 380d
Cleared Feb 02, 2023
Wee Bell
K221356 · HFX
Wee Medical
Obstetrics & Gynecology · 268d
Cleared Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible...
K221515 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 253d
Cleared Feb 02, 2023
Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
K221781 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 226d
Cleared Feb 02, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional
K222211 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 192d
Cleared Feb 02, 2023
Polaris Valve Electronic Reading Instrument
K222422 · JXG
Sophysa
Neurology · 175d
Cleared Feb 02, 2023
DeltaScan Patch
K222671 · GXY
Prolira B.V.
Neurology · 149d