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
9169–9192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2023
Natural Cycles
K231274 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 114d
Cleared Aug 24, 2023
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · JDQ
Arthrex, Inc.
Orthopedic · 141d
Cleared Aug 24, 2023
Plum Duo™ Infusion System
K223607 · FRN
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
K223606 · PHC
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
APS Metal Plate & Screw System
K223150 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 323d
Cleared Aug 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · LZA
Shandong Yinghng Medical Products...
General Hospital · 402d
Cleared Aug 24, 2023
Monaghan medical filtered mouthpiece kit
K220145 · CAF
Monaghan Medical Corporation
Anesthesiology · 582d
Cleared Aug 24, 2023
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K220085 · OIF
Kronus, Inc.
Chemistry · 590d
Cleared Aug 24, 2023
Maxiocel Chitosan Wound Dressing
K212766 · KGN
Advamedica, Inc.
General & Plastic Surgery · 723d
Cleared Aug 23, 2023
EVO 700 series high speed handpiece
K232243 · EFB
Ttbio Corp.
Dental · 26d
Cleared Aug 23, 2023
VITROS Immunodiagnostic Products CEA Reagent Pack
K231517 · DHX
Ortho-Clinical Diagnostics
Immunology · 90d
Cleared Aug 23, 2023
Withings Scan Monitor 2.0
K230812 · DPS
Withings
Cardiovascular · 152d
Cleared Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610 · FYA
Dongguan Shin YI Healthcare Products...
General Hospital · 170d
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