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
36961–36984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2014
COCOON CONVECTIVE WARMING SYSTEM
K140635 · DWJ
Care Essentials Pty, Ltd.
Cardiovascular · 135d
Cleared Jul 25, 2014
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
K140770 · MAX
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Jul 25, 2014
ZQUIET-SA
K140777 · LRK
Sleeping Well, LLC
Dental · 119d
Cleared Jul 25, 2014
EDS COMBO-RINSE
K140846 · KJJ
Essential Dental Systems, Inc.
Dental · 113d
Cleared Jul 25, 2014
LIAISON XL ANALYZER
K141116 · LOL
DiaSorin, Inc.
Microbiology · 86d
Cleared Jul 25, 2014
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER...
K141193 · PHC
Smiths Medical Asd, Inc.
General Hospital · 78d
Cleared Jul 25, 2014
0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH
K141311 · NGT
Becton, Dickinson and Company
General Hospital · 66d
Cleared Jul 25, 2014
HARD PACK SYRINGE
K141359 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 63d
Cleared Jul 25, 2014
LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND...
K141367 · GDW
Touchstone International Medical...
General & Plastic Surgery · 63d
Cleared Jul 25, 2014
VOLUSON P6, VOLUSON P8
K141675 · IYN
Ge Healthcare
Radiology · 30d
Cleared Jul 25, 2014
PHILIPS PROGRADE
K141736 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jul 25, 2014
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
K141838 · GEX
Regulatory Technology Services, LLC
General & Plastic Surgery · 17d
Cleared Jul 24, 2014
NOVAPROBE LED LIGHT SOURCE
K131226 · FCW
Novaprobe Incorporated
Gastroenterology & Urology · 450d
Cleared Jul 24, 2014
THERMOPULSE
K131926 · IMJ
Ibramed Equipamentos Medicos
Physical Medicine · 393d
Cleared Jul 24, 2014
NOBELPROCERA OVERDENTURE BAR
K132749 · NHA
Nobel Biocare USA, LLC
Dental · 324d
Cleared Jul 24, 2014
PLIF LITE AND TLIF LITE
K132907 · MAX
Sintea Plustek
Orthopedic · 310d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 280d
Cleared Jul 24, 2014
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED...
K133336 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 268d
Cleared Jul 24, 2014
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
K133670 · LNH
Neocoil, LLC
Radiology · 237d
Cleared Jul 24, 2014
MICR02 OSA DEVICE
K133683 · LRK
Microdental, Inc.
Dental · 234d
Cleared Jul 24, 2014
C-JAWS CERVICAL COMPRESSIVE STAPLE
K133906 · PHQ
Medicrea International
Orthopedic · 213d
Cleared Jul 24, 2014
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096 · DRX
Hmicro, Inc.
Cardiovascular · 191d
Cleared Jul 24, 2014
FLEXI-LUME LED SYSTEM
K140281 · EBZ
Epic Medical Concepts & Innovations
Dental · 170d
Cleared Jul 24, 2014
GIS ENDOSCOPIC OPTICAL LENS
K140295 · FDS
Gi Scientific, LLC
Gastroenterology & Urology · 168d