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
7465–7488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2024
Calibra Abutment Resin Cement
K240888 · EMA
Dentsply Sirona
Dental · 1d
Cleared Apr 02, 2024
SnapshotNIR model KD205
K240601 · MUD
Kent Imaging, Inc.
General & Plastic Surgery · 29d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
Cleared Apr 02, 2024
Zoom 6F Insert Catheters
K233975 · DQO
Imperative Care, Inc.
Cardiovascular · 109d
Cleared Apr 02, 2024
ECG-less Cardiac
K233750 · JAK
Ge Medical Systems, LLC
Radiology · 132d
Cleared Apr 02, 2024
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
K232835 · JAK
Canon Medical Systems Corporation
Radiology · 201d
Cleared Apr 02, 2024
R&G Surgical Mask
K232112 · FXX
R&G Seguridad E Higiene Industrial...
General Hospital · 263d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · SAN
Affinity Biosensors
Microbiology · 1026d
Cleared Apr 01, 2024
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag,...
K240635 · GCJ
Ximedica
General & Plastic Surgery · 26d
Cleared Apr 01, 2024
MagnetOs Putty
K240442 · MQV
Kuros Biosciences B.V
Orthopedic · 47d
Cleared Apr 01, 2024
AlphaVac MMA F1885 System (H787253020)
K240397 · QEZ
AngioDynamics, Inc.
Cardiovascular · 52d
Cleared Apr 01, 2024
SF Push- in Anchor
K240288 · MAI
Surgical Fusion Technologies GmbH
Orthopedic · 60d
Cleared Apr 01, 2024
EVOLUTION® Hinge Knee System
K240043 · KRO
Microport Orthopedics, Inc.
Orthopedic · 87d
Cleared Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K233990 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 105d
Cleared Apr 01, 2024
Us2.v2
K233676 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 137d
Cleared Apr 01, 2024
Talis EMR with Talis +ACG (Talis EMR with +ACG)
K233133 · MWI
Talis Clinical, LLC
Cardiovascular · 187d
Cleared Apr 01, 2024
External Hex Implant System
K232726 · DZE
Southern Implants (Pty), Ltd.
Dental · 208d
Cleared Apr 01, 2024
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO
K230895 · EBW
Cefla S.C.
Dental · 367d
Cleared Mar 30, 2024
Rejoyn
K231209 · SAP
Otsuka America Pharmaceutical, Inc.
Neurology · 338d
Cleared Mar 29, 2024
MAGNETOM Viato.Mobile
K240608 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Mar 29, 2024
SmoothSkin Pure Unplugged (SSB3)
K240587 · OHT
Cyden Limited
General & Plastic Surgery · 28d
Cleared Mar 29, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · PGY
Shenzhen Beacon Display Technology...
Radiology · 56d
Cleared Mar 29, 2024
AlignRT Plus
K233622 · IYE
Vision Rt, Ltd.
Radiology · 137d
Cleared Mar 29, 2024
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · OLO
Genesys Spine
Orthopedic · 142d