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
100753–100776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1995
ACCESS MYOGLOBIN REAGENTS
K951634 · DDR
Bio-Rad Laboratories, Inc.
Chemistry · 173d
Cleared Sep 27, 1995
MICROTIME
K952616 · BTI
Westmed Intl.
Anesthesiology · 113d
Cleared Sep 27, 1995
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
K952928 · KWS
Tornier
Orthopedic · 93d
Cleared Sep 27, 1995
EZ-PERSONAL PROTECTION KIT
K952962 · FXX
Safetec of America, Inc.
General Hospital · 93d
Cleared Sep 27, 1995
AS/3 NETWORK LINK
K953006 · CCK
Datex Medical Instrumentation, Inc.
Anesthesiology · 91d
Cleared Sep 27, 1995
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K953045 · LZO
Biologically Oriented Prostheses
Orthopedic · 89d
Cleared Sep 27, 1995
ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)
K953065 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 27, 1995
FUJI BOND LC
K953166 · KLE
GC America, Inc.
Dental · 82d
Cleared Sep 27, 1995
IVAC BALL VALCE ADMIN. SETS
K953225 · FPA
Y
General Hospital · 79d
Cleared Sep 27, 1995
HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
K953379 · LYY
Ansell, Inc.
General Hospital · 70d
Cleared Sep 27, 1995
PROP. CONQUEST C&B VLC GLAZE/SEALANT
K953381 · EBI
Jeneric/Pentron, Inc.
Dental · 70d
Cleared Sep 27, 1995
HEMA-BENZ
K953405 · KLE
Health-Dent Intl., Inc.
Dental · 69d
Cleared Sep 27, 1995
UNSCENTED MENSTRAL PAD WITH WINGS
K953666 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 51d
Cleared Sep 27, 1995
UNSCENTED CURVED MAXI PAD
K953700 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 50d
Cleared Sep 27, 1995
AXSYM REA ETHANOL
K953765 · DML
Abbott Laboratories
Toxicology · 47d
Cleared Sep 27, 1995
BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY
K953774 · DZE
Nobelpharma USA, Inc.
Dental · 44d
Cleared Sep 27, 1995
904 SLIT LAMP
K953965 · HJO
Clement Clarke, Inc.
Ophthalmic · 36d
Cleared Sep 27, 1995
ARTGLASS & KEVLOC
K954115 · EBF
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Sep 27, 1995
ALPHA-BOND DENTIN BONDING SYSTEM
K954177 · EMA
Alpha-Bond, Inc.
Dental · 22d
Cleared Sep 27, 1995
Q5. 5-5.5NPB-2.5HW
K954292 · LRJ
Central Solutions, Inc.
General Hospital · 13d
Cleared Sep 26, 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
K930191 · HRX
Sofamor Danek Mfg., Inc.
Orthopedic · 985d
Cleared Sep 26, 1995
CHARTR ENG SYSTEM
K931609 · GWM
Ics Medical Corp.
Neurology · 908d
Cleared Sep 26, 1995
THE HEPANORM HBPM/LMWH KIT
K943514 · KFF
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HBPM/LMWH CONTROL KIT
K943519 · KFF
American Bioproducts Co.
Hematology · 432d