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
9457–9480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
K230079 · KGO
Ansell Healthcare Products, LLC
General Hospital · 225d
Cleared Aug 23, 2023
Access Folate Assay
K223590 · CGN
Beckman Coulter, Inc.
Chemistry · 265d
Cleared Aug 23, 2023
Oneday Mini Implant System
K222946 · DZE
Oneday Biotech Co., Ltd.
Dental · 330d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 22, 2023
Zavation Connector System
K231811 · NKB
Zavation Medical Products, LLC
Orthopedic · 62d
Cleared Aug 22, 2023
Surgical Gown (S,M,L,XL,XXL,XXXL)
K231510 · FYA
Xiantao Zhibo Non-Woven Products Co.,...
General Hospital · 89d
Cleared Aug 22, 2023
CUPTIMIZE™ Advanced
K231503 · LLZ
DePuy Orthopaedics, Inc.
Radiology · 90d
Cleared Aug 22, 2023
TITAN 3-D Wedge System
K231496 · PLF
Paragon 28, Inc.
Orthopedic · 90d
Cleared Aug 22, 2023
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · LFD
Gurunanda, LLC
Dental · 117d
Cleared Aug 22, 2023
qXR-PTX-PE
K230899 · QFM
Qure.Ai Technologies
Radiology · 144d
Cleared Aug 22, 2023
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450...
K223574 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 265d
Cleared Aug 22, 2023
Nova HD+
K220938 · NGX
Aura Wellness, LLC
Physical Medicine · 509d
Cleared Aug 21, 2023
SM-IV
K232185 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Aug 21, 2023
Grappler Suture Anchor System
K231867 · MBI
Paragon 28, Inc.
Orthopedic · 56d
Cleared Aug 21, 2023
Stable-C Interbody System
K231763 · OVE
Nexus Spine, LLC
Orthopedic · 66d
Cleared Aug 21, 2023
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -...
K231731 · KPS
Mcgovern Medical School
Radiology · 69d
Cleared Aug 21, 2023
Pediatric Nailing Platform Tibia
K231266 · HSB
OrthoPediatrics Corp.
Orthopedic · 111d
Cleared Aug 21, 2023
Cove Strip
K230486 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 179d
Cleared Aug 21, 2023
Aveta System 2.0
K223813 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 244d
Cleared Aug 21, 2023
Plato 17 Microcatheter
K223560 · QJP
Scientia Vascular, Inc.
Neurology · 266d
Cleared Aug 21, 2023
ACR Screw System
K222245 · OAT
Biomaterials Korea, Inc.
Dental · 391d
Cleared Aug 19, 2023
LUX-Dx II (M302)
K231328 · MXD
Boston Scientific Corp
Cardiovascular · 103d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro -...
K232498 · EBC
Ultradent Product, Inc.
Dental · 1d
Cleared Aug 18, 2023
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K232157 · GCJ
Stryker Corporation
General & Plastic Surgery · 29d