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
40249–40272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jul 10, 2013
DERMA HOOD
K131338 · PEQ
Globalmedia Group, LLC
General Hospital · 62d
Cleared Jul 10, 2013
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
K131496 · DWL
Bsn Medical, Inc.
General Hospital · 48d
Cleared Jul 10, 2013
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND...
K131738 · DHB
Phadia AB
Immunology · 27d
Cleared Jul 09, 2013
STATSEAL DISC
K130324 · QSY
Biolife, LLC
General & Plastic Surgery · 151d
Cleared Jul 09, 2013
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
K130879 · FPA
Nexus Medical, LLC
General Hospital · 102d
Cleared Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC...
K131072 · OCY
Coloplast A/S
Gastroenterology & Urology · 83d
Cleared Jul 08, 2013
AMBIO REMOTE HEALTH MONITORING SYSTEM
K130676 · DRG
Arrayent Health, LLC D/B/A Ambio Health
Cardiovascular · 118d
Cleared Jul 08, 2013
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K131463 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 48d
Cleared Jul 07, 2013
SFI BAR ABUTMENTS
K130183 · NHA
Sterngold Dental, LLC
Dental · 163d
Cleared Jul 05, 2013
TRANSCORP ACIF SYSTEM
K121178 · ODP
Transcorp, Inc.
Orthopedic · 443d
Cleared Jul 05, 2013
ISUS IMPLANT SUPRASTRUCTURES
K122424 · NHA
Dentsply International, Inc.
Dental · 330d
Cleared Jul 05, 2013
ERMIS STERILIZATION CONTAINER SYSTEM
K123234 · KCT
Ermis Medizintechnik
General Hospital · 263d
Cleared Jul 05, 2013
ETII SA FIXTURE SYSTEM
K123471 · DZE
Hiossen, Inc.
Dental · 234d
Cleared Jul 05, 2013
AIRVIEW BOWIE DICK
K130211 · JOJ
Spsmedical Supply Corp.
General Hospital · 157d
Cleared Jul 05, 2013
TIBURON SURGICAL DRAPE
K130404 · KKX
Cardinal Health200, LLC
General Hospital · 136d
Cleared Jul 05, 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · LZA
Hartalega Sdn Bhd
General Hospital · 133d
Cleared Jul 05, 2013
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · MED
STERIS Corporation
General Hospital · 79d
Cleared Jul 05, 2013
CLICKFINE AUTOPROTECT PEN NEEDLE
K131123 · FMI
Ypsomed AG
General Hospital · 74d
Cleared Jul 05, 2013
CLICKFINE PEN NEEDLE
K131125 · FMI
Ypsomed AG
General Hospital · 74d
Cleared Jul 05, 2013
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
K131283 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jul 05, 2013
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE...
K131511 · GDW
Changzhou Sinolinks Medical...
General & Plastic Surgery · 38d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599 · GNX
Quidel Corporation
Microbiology · 32d
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606 · GNX
Quidel Corp.
Microbiology · 32d