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
7489–7512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With...
K240051 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 52d
Cleared Feb 29, 2024
Curiteva Thoracolumbar Plate System
K233360 · KWQ
Curiteva, Inc.
Orthopedic · 153d
Cleared Feb 29, 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971 · NRY
Alembic, LLC
Neurology · 161d
Cleared Feb 29, 2024
Balloon Inflation System
K232842 · NDN
Ningbo Hicren Biotechnology Co., Ltd.
Orthopedic · 168d
Cleared Feb 29, 2024
MAGNETOM Cima.X Fit
K232765 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Feb 29, 2024
inHEART Models
K231683 · QIH
Inheart, Sas
Radiology · 265d
Cleared Feb 29, 2024
PlazMagik
K230837 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 339d
Cleared Feb 28, 2024
OsteoCool™ 2.0 RF Ablation System
K233830 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 89d
Cleared Feb 28, 2024
Intra.Ox™ 2.0 Handheld Tissue Oximeter
K233488 · MUD
Vioptix, Inc.
General & Plastic Surgery · 124d
Cleared Feb 28, 2024
Dawn Diode Laser System
K232885 · NVK
Shanghai Wonderful Opto-Electrics...
Dental · 163d
Cleared Feb 28, 2024
CT Cardiomegaly
K232613 · QIH
Innolitics, LLC
Radiology · 184d
Cleared Feb 28, 2024
PowerWire Radiofrequency Guidewire Kit
K232562 · PDU
Baylis Medical Technologies, Inc.
Cardiovascular · 188d
Cleared Feb 28, 2024
Dental unit Model: Mare
K231845 · EIA
Foshan Safety Medical Equipment Co.,...
Dental · 251d
Cleared Feb 27, 2024
Obsidian® NOW
K234014 · EIH
Prismatik Dentalcraft, Inc.
Dental · 70d
Cleared Feb 27, 2024
Camber Sacroiliac (SI) Fixation System
K233972 · OUR
Camber Spine Technologies
Orthopedic · 74d
Cleared Feb 27, 2024
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview...
K233879 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 81d
Cleared Feb 27, 2024
Praxiject™ SP 0.9% NaCl
K233623 · NGT
Medxl, Inc.
General Hospital · 106d
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435 · KLW
Pnq Health
Ear, Nose, Throat · 137d
Cleared Feb 27, 2024
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW...
K232607 · NKB
Solco Biomedical Copany India Private...
Orthopedic · 183d
Cleared Feb 27, 2024
ARK Levetiracetam II Assay
K232522 · ORI
ARK Diagnostics, Inc.
Toxicology · 193d
Cleared Feb 27, 2024
Coresculpt & Magsculpt
K222400 · NGX
K1Med Co., Ltd.
Physical Medicine · 567d
Cleared Feb 26, 2024
Dexcom G7 Continuous Glucose Monitoring System
K234133 · QBJ
Dexcom, Inc.
General & Plastic Surgery · 59d
Cleared Feb 26, 2024
FMS VUE™ Fluid Management and Tissue Debridement System
K233675 · HRX
DePuy Mitek, Inc.
Orthopedic · 102d
Cleared Feb 26, 2024
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential...
K233560 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d