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
9433–9456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2023
072 Aspiration System
K222786 · NRY
Q'Apel Medical, Inc.
Neurology · 344d
Cleared Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood...
K213670 · GIM
Becton, Dickinson and Company
Hematology · 641d
Cleared Aug 24, 2023
Essenz HLM, Essenz ILBM
K232291 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 23d
Cleared Aug 24, 2023
Zenius™ Spinal System
K232218 · NKB
Medyssey USA, Inc.
Orthopedic · 29d
Cleared Aug 24, 2023
Quantra Hemostasis Analyzer
K232215 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Aug 24, 2023
CATAMARAN SI Joint Fusion System
K231944 · OUR
Tenon Medical, Inc.
Orthopedic · 55d
Cleared Aug 24, 2023
AccelFix Lumbar Expandable Cage System
K231680 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 76d
Cleared Aug 24, 2023
Instrument Case
K231604 · KCT
Cochlear Americas
General Hospital · 84d
Cleared Aug 24, 2023
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · DZL
Stryker Leibinger GmbH & Co KG
Dental · 84d
Cleared Aug 24, 2023
ZENEX FreeMilling & CCM Cast Abutment
K231557 · NHA
Izenimplant Co., Ltd.
Dental · 86d
Cleared Aug 24, 2023
Current Health System
K231506 · MSX
Current Health , Ltd.
Cardiovascular · 92d
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