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
85177–85200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1999
BACTALERT FA
K992400 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
BACT/ALERT PF
K992401 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 1
K992576 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 2
K992578 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
O2N DEMAND-II, VICTOR MODEL OCPR-II
K992659 · NFB
Thermadyne Holings Corp.
Anesthesiology · 25d
Cleared Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992677 · KGI
Hologic, Inc.
Radiology · 24d
Cleared Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · MUJ
Varian Assoc., Inc.
Radiology · 18d
Cleared Sep 03, 1999
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · EGY
Dental X-Ray Support Systems, Inc.
Radiology · 7d
Cleared Sep 02, 1999
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL...
K990867 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 170d
Cleared Sep 02, 1999
SAGE CONTRAST MANAGEMENT SYSTEM
K991112 · FPA
Sage Laboratories, Inc.
General Hospital · 154d
Cleared Sep 02, 1999
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · BSB
Stihler Electronic GmbH
Hematology · 148d
Cleared Sep 02, 1999
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · JGJ
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 02, 1999
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · CJE
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 02, 1999
SOOTHE-N-SEAL CANKER SORE RELIEF
K991923 · MZW
Closure Medical Corp.
Dental · 87d
Cleared Sep 02, 1999
DR. B'S MOUTHPIECE, MODEL 32129-10002
K991948 · LRK
Snore - Ezzer
Dental · 85d
Cleared Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
K992172 · JJY
Bio-Rad
Chemistry · 66d
Cleared Sep 02, 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748 · DIO
Syntron Bioresearch, Inc.
Toxicology · 17d
Cleared Sep 01, 1999
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER...
K974387 · KDJ
Microwave Medical Systems, Inc.
Gastroenterology & Urology · 649d
Cleared Sep 01, 1999
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR...
K990338 · DXN
Physio-Control Corp.
Cardiovascular · 210d
Cleared Sep 01, 1999
CUFF-ABLE PLUS
K990412 · DXQ
Vital Signs, Inc.
Cardiovascular · 203d
Cleared Sep 01, 1999
INTRASTENT II
K990592 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 189d
Cleared Sep 01, 1999
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
K990873 · JMT
Ameritek, Inc.
Chemistry · 169d
Cleared Sep 01, 1999
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH...
K991899 · GWF
Nihon Kohden America, Inc.
Neurology · 89d
Cleared Sep 01, 1999
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
K991905 · HGM
General Electric Medical Systems...
Obstetrics & Gynecology · 89d