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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75073–75096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2002
PHFW-10
K021592 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 61d
Cleared Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
K022038 · DZE
Paxmed International
Dental · 21d
Cleared Jul 13, 2002
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
K020585 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 141d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · JIF
Bayer Diagnostics Corp.
Chemistry · 94d
Cleared Jul 13, 2002
ULTRAQUIET
K021202 · KLW
Sound Technique System, LLC
Ear, Nose, Throat · 88d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · KXK
Cp Medical
Radiology · 79d
Cleared Jul 13, 2002
BACTEC MGIT 960 PZA KIT
K021582 · MJA
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jul 12, 2002
MEDX 1000 SERIES
K020017 · ILY
Medx Electronics, Inc.
Physical Medicine · 190d
Cleared Jul 12, 2002
MEDICAL ADMINISTRATOR
K020073 · LLZ
Barco N.V.
Radiology · 184d
Cleared Jul 12, 2002
3D KNEE
K020114 · JWH
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 12, 2002
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020735 · GXY
Cathay International, Ltd.
Neurology · 128d
Cleared Jul 12, 2002
EXTENSION SET, MODELS 1911-512
K020926 · FPA
Epimed International, Inc.
General Hospital · 113d
Cleared Jul 12, 2002
MECHANICAL DAILY USE WHEELCHAIR
K021075 · IOR
First World Services, Inc.
Physical Medicine · 101d
Cleared Jul 12, 2002
NERVUS MONITOR
K021185 · OLV
Taugagreining HF
Neurology · 88d
Cleared Jul 12, 2002
AUTOALIGN
K021191 · LLZ
Cortechs Labs, Inc.
Radiology · 88d
Cleared Jul 12, 2002
PRIMECHAIR
K021199 · ITI
Dalton Medical Corp.
Physical Medicine · 87d
Cleared Jul 12, 2002
ENDOCERVICAL BLOCK NEEDLE
K021224 · HEE
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 12, 2002
ATAC PAK BUN REAGENT
K021385 · CDQ
Elan Diagnostics
Chemistry · 71d
Cleared Jul 12, 2002
TOPCUT
K021525 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 63d
Cleared Jul 12, 2002
HEMOSORB
K021581 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 59d
Cleared Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · JJX
Bionostics, Inc.
Chemistry · 57d