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
72913–72936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8005
K023843 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 14, 2003
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K023848 · MOS
Igc-Medical Advances, Inc.
Radiology · 87d
Cleared Feb 14, 2003
SAMARITAN AED, MODEL SAM-01
K023854 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 87d
Cleared Feb 14, 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · EGS
St. George Technology, Inc.
Dental · 79d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Contamac, Ltd.
Ophthalmic · 70d
Cleared Feb 14, 2003
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K024071 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 66d
Cleared Feb 14, 2003
4 SEASONS
K024094 · EBF
Ivoclar Vivadent, Inc.
Dental · 65d
Cleared Feb 14, 2003
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS...
K024097 · CAC
Summit Medical , Ltd.
Anesthesiology · 64d
Cleared Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · MQP
Depuyacromed
Orthopedic · 21d
Cleared Feb 13, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5
K021588 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 275d
Cleared Feb 13, 2003
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX
K022815 · LYY
Pt. Smartglove Indonesia
General Hospital · 171d
Cleared Feb 13, 2003
6203
K022865 · NFB
Contemporary Products, Inc.
Anesthesiology · 169d
Cleared Feb 13, 2003
SMARTSET HV BONE CEMENT
K023012 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 156d
Cleared Feb 13, 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 150d
Cleared Feb 13, 2003
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
K023974 · LYY
Top Glove Sdn. Bhd.
General Hospital · 73d
Cleared Feb 13, 2003
N LATEX IGA
K024038 · CZP
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 13, 2003
DAVOL ARTHROVENT OUTFLOW TUBING
K030307 · HRX
Davol, Inc.
Orthopedic · 15d
Cleared Feb 12, 2003
SLEEPSCREEN/APNOESCREEN CARDIO
K021138 · MNR
Erich Jaeger GmbH
Anesthesiology · 309d
Cleared Feb 12, 2003
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
K021193 · HDB
Fortune Medical Instrument Corp.
Obstetrics & Gynecology · 303d
Cleared Feb 12, 2003
MINOLTA PULSOX-2
K021469 · DQA
Konica Minolta Sensing, Inc.
Anesthesiology · 281d
Cleared Feb 12, 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04...
K021580 · LJT
LeMaitre Vascular, Inc.
General Hospital · 274d
Cleared Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K021962 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 243d
Cleared Feb 12, 2003
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K022532 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 196d
Cleared Feb 12, 2003
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 100d