Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
71713–71736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 26, 2003
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K032236 · LYZ
Est International Corporation
General Hospital · 36d
Cleared Aug 26, 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 35d
Cleared Aug 26, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K032272 · LYZ
Est International Corporation
General Hospital · 34d
Cleared Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · HNO
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Aug 26, 2003
MODIFICATION TO OUTBACK CATHETER
K032298 · DQY
Lumend, Inc.
Cardiovascular · 32d
Cleared Aug 26, 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376 · DQO
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Aug 25, 2003
VISUALINE METHADONE DIPSTRIPTEST
K023856 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 279d