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
24265–24288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2018
CRP Vario
K173833 · NQD
SENTINEL CH. SpA
Chemistry · 283d
Cleared Sep 27, 2018
EmboCube Embolization Gelatin
K181021 · KRD
Biosphere Medical, S.A.
Cardiovascular · 163d
Cleared Sep 27, 2018
PureSet Tray
K181075 · KCT
Nobel Biocare AB
General Hospital · 156d
Cleared Sep 27, 2018
DualX
K181397 · MAX
Innovasive, Inc.
Orthopedic · 121d
Cleared Sep 27, 2018
Disposable Standard Clamp
K181608 · GCJ
Standard Bariatrics
General & Plastic Surgery · 100d
Cleared Sep 27, 2018
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K181742 · KWS
Stryker GmbH
Orthopedic · 87d
Cleared Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
K181975 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 65d
Cleared Sep 27, 2018
Acculoc Total Knee System
K182370 · JWH
Rootloc Co., Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
CarboClear® Pedicle Screw System
K182377 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
CoLink View Plating System
K182402 · HRS
In2bones USA, LLC
Orthopedic · 23d
Cleared Sep 26, 2018
Stat Profile Prime Plus Analyzer System
K180340 · CGA
Nova Biomedical Corporation
Chemistry · 231d
Cleared Sep 26, 2018
BeautiBond Universal
K180803 · KLE
Shofu Dental Corporation
Dental · 182d
Cleared Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and...
K181066 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 156d
Cleared Sep 26, 2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex...
K181563 · DQY
Access Scientific, LLC
Cardiovascular · 104d
Cleared Sep 26, 2018
Fixated Asfora BULLET CAGE® (FABC)
K181591 · MAX
Medical Designs, LLC
Orthopedic · 100d
Cleared Sep 26, 2018
Everyway Wireless TENS & EMS Unit
K181707 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Sep 26, 2018
NxStage Connected Health System
K181991 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 26, 2018
InMode RF System
K182325 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 30d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Sep 25, 2018
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1...
K173127 · LCP
Skyla Corporation H.S.P.B
Chemistry · 361d
Cleared Sep 25, 2018
PeDIA
K181424 · BTC
Pedia, LLC
Anesthesiology · 117d
Cleared Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag...
K181692 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2018
Synapse 3D Optional Tools
K181773 · LLZ
Fujifilm Corporation
Radiology · 84d