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
7009–7032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2024
SmartAdjust(TM) technology
K232741 · QJI
Insulet Corporation
Chemistry · 265d
Cleared May 29, 2024
EasyScreen Gastrointestinal Parasite Detection Kit
K232672 · PCH
Genetic Signatures Limited
Microbiology · 271d
Cleared May 28, 2024
React 71 Catheter
K241177 · DQY
Micro Therapeutics Lnc. D/B/A Ev3...
Neurology · 29d
Cleared May 28, 2024
Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
K240874 · GEX
Theralaser Medtech (China) Co., Ltd.
General & Plastic Surgery · 60d
Cleared May 28, 2024
PILLAR SA Ti Spacer System (82-XXX)
K240749 · MAX
Orthofix, Inc.
Orthopedic · 70d
Cleared May 28, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K240629 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 83d
Cleared May 28, 2024
EVOLVE Nitric Oxide Delivery System
K240410 · MRN
Malinckrodt Manufacturing, LLC
Anesthesiology · 106d
Cleared May 28, 2024
ANNE Limb
K240305 · DQA
Sibel Health, Inc.
Cardiovascular · 116d
Cleared May 28, 2024
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR...
K240304 · KIF
Enpuno Biotechnology Co., Ltd.
Dental · 116d
Cleared May 28, 2024
Regenalase Laser System
K233344 · GEX
Ipg Medical
General & Plastic Surgery · 242d
Cleared May 28, 2024
Laser Speckle Imaging System (RFLSI CZW)
K233076 · DPT
Rwd Life Science Co., Ltd.
General & Plastic Surgery · 245d
Cleared May 28, 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · BTY
Eresearchtechnology GmbH
Cardiovascular · 540d
Cleared May 24, 2024
DEKA ACE Pump System
K241178 · QFG
Deka Research and Development
Chemistry · 25d
Cleared May 24, 2024
PacePro Wire
K240864 · DQX
Opsens, Inc.
Cardiovascular · 57d
Cleared May 24, 2024
SET-5002
K240827 · KPS
Shimadzu Corporation Medical Systems...
Radiology · 59d
Cleared May 24, 2024
Anti Grinding Guard
K240810 · OBR
Xiamen Yizhou Imp. & Exp. Co., Ltd.
Dental · 60d
Cleared May 24, 2024
LVivo IQS
K240769 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 64d
Cleared May 24, 2024
da Vinci Xi Surgical System (IS4000)
K240723 · NAY
Intuitive Surgical
General & Plastic Surgery · 67d
Cleared May 24, 2024
Wolff's Law Anterior Cervical Plate System
K240592 · KWQ
Spinal Simplicity, LLC
Orthopedic · 84d
Cleared May 24, 2024
uPMR 790
K234154 · OUO
Shanghai United Imaging Healthcare...
Radiology · 147d
Cleared May 24, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · FRG
Primed Medical Products, Inc.
General Hospital · 182d
Cleared May 24, 2024
Monik™ - Disposable Endoscopic Trocar
K233386 · GCJ
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 235d
Cleared May 24, 2024
KATANA Zirconia ONE For IMPLANT
K233285 · NHA
Kuraray Noritake Dental, Inc.
Dental · 238d
Cleared May 24, 2024
ALGS2 Ag Alginate Wound Dressing Rx
K233111 · FRO
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 240d