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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,820 results
97585–97608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1996
MODEL 2188 CORONARY SINUS LEAD.
K961936 · DTB
Medtronic Vascular
Cardiovascular · 87d
Cleared Aug 15, 1996
DHD ACE WITH MASK KIT
K961973 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared Aug 15, 1996
PLASTIC PROTECTION HEALING CAPS
K962023 · DZE
The Straumann Co.
Dental · 84d
Cleared Aug 15, 1996
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · CAF
Baxter Healthcare Corp
Anesthesiology · 72d
Cleared Aug 15, 1996
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K962215 · HWE
U.S. Medical Products, Inc.
Orthopedic · 66d
Cleared Aug 15, 1996
MOORE TRACHEOSTOMY TUBE
K962240 · BTO
Boston Medical Products, Inc.
Anesthesiology · 65d
Cleared Aug 15, 1996
HICHEM CK/NAC REAGENT KIT
K962247 · CGS
Elan Pharma, Inc.
Chemistry · 65d
Cleared Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · DDR
Bayer Corp.
Immunology · 58d
Cleared Aug 15, 1996
ELECSYS T3
K962508 · CDP
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Aug 15, 1996
ACA PLUS FT4 CALIBRATOR
K962594 · JIT
Dade Intl., Inc.
Chemistry · 44d
Cleared Aug 15, 1996
ACA PLUS FREE THYROXINE(FT4) METHOD
K962602 · CEC
Dade Intl., Inc.
Chemistry · 44d
Cleared Aug 15, 1996
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
K962650 · LYY
Sti Medical Sdn Bhd
General Hospital · 38d
Cleared Aug 15, 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · DIS
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Aug 15, 1996
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · DJR
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Aug 15, 1996
OPUS MYOGLOBIN CONTROLS
K962841 · JJX
Behring Diagnostics, Inc.
Immunology · 24d
Cleared Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · JJY
Nova Biomedical Corp.
Chemistry · 13d
Cleared Aug 14, 1996
SICKLE-2000
K955719 · GIQ
Medicus Technologies, Inc.
Hematology · 240d
Cleared Aug 14, 1996
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
K955931 · HGM
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 243d
Cleared Aug 14, 1996
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
K960474 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 194d
Cleared Aug 14, 1996
GORE BURR HOLE COVER
K960656 · GXR
W.L. Gore & Associates, Inc.
Neurology · 181d
Cleared Aug 14, 1996
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · JBQ
Medical Diagnostic Technologies, Inc.
Hematology · 163d
Cleared Aug 14, 1996
DURAFLOR
K961893 · LBH
Pharmascience, Inc.
Dental · 90d
Cleared Aug 14, 1996
MDI TUTOR
K961894 · CCQ
Mdi Tutor, Inc.
Anesthesiology · 90d
Cleared Aug 14, 1996
BACTERIA/VIRAL FILTER
K961914 · CAH
Hudson Respiratory Care, Inc.
General Hospital · 89d