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
70585–70608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2003
TSO3 OZONE CHEMICAL INDICATOR
K021161 · JOJ
Technologies of Sterilization With...
General Hospital · 503d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · DJR
Microgenics Corp.
Toxicology · 302d
Cleared Aug 27, 2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K030381 · BTO
Portex , Ltd.
Anesthesiology · 203d
Cleared Aug 27, 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60,...
K030525 · MQG
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Aug 27, 2003
MICROPEAK
K030586 · BZH
Micro Direct, Inc.
Anesthesiology · 184d
Cleared Aug 27, 2003
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · HIB
Kentron Health Care, Inc.
Obstetrics & Gynecology · 175d
Cleared Aug 27, 2003
MOBILE BATTERY SERVICE STATION (MBSS)
K030898 · MKJ
Ad Elektronik GmbH
Cardiovascular · 159d
Cleared Aug 27, 2003
D-10 HEMOGLOBIN A1C
K031043 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 148d
Cleared Aug 27, 2003
HEARTSTART MRX, MODEL M3535A
K031187 · MKJ
Philips Medical Systems
Cardiovascular · 134d
Cleared Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K031665 · HQF
Iridex Corp
Ophthalmic · 90d
Cleared Aug 27, 2003
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
K031748 · EZL
Vitalcare Group, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 27, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Aug 27, 2003
LCD MONITOR, RADIFORCE G11, G31, G51
K032026 · LLZ
Eizo Nanao Corporation
Radiology · 58d
Cleared Aug 27, 2003
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · DWF
LeMaitre Vascular, Inc.
Cardiovascular · 57d
Cleared Aug 27, 2003
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K032069 · DQY
AngioDynamics, Inc.
Cardiovascular · 55d
Cleared Aug 27, 2003
ELCACAM
K032070 · EIA
A-Dec, Inc.
Dental · 55d
Cleared Aug 27, 2003
CLICK HOLTER
K032276 · MWJ
Remco Italia S.P.A.
Cardiovascular · 35d
Cleared Aug 27, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM...
K032360 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Aug 27, 2003
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
K032498 · NHA
Straumann USA
Dental · 14d
Cleared Aug 26, 2003
TSO3 OZONE STERILIZER, MODEL 125L
K020875 · FLF
Technologies of Sterilization With...
General Hospital · 526d
Cleared Aug 26, 2003
UROPOWER
K022721 · EXY
W.O.M. World of Medicine AG
Gastroenterology & Urology · 375d
Cleared Aug 26, 2003
OASYS-ORAL AIRWAY SYSTEM
K030440 · LRK
Mark Abramson, D.D.S., Inc.
Dental · 196d
Cleared Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 26, 2003
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
K031740 · DQA
Welch Allyn Protocol, Inc.
Anesthesiology · 83d