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
81409–81432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2000
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF...
K002593 · KGO
Hartalega Sdn Bhd
General Hospital · 100d
Cleared Nov 29, 2000
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
K002721 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Nov 29, 2000
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD...
K002781 · DSA
Medical Cables, Inc.
Cardiovascular · 84d
Cleared Nov 29, 2000
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
K002787 · DQA
Palco Labs, Inc.
Anesthesiology · 83d
Cleared Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION...
K002834 · HIR
Srs Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 29, 2000
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
K002861 · JOJ
Steritec Products, Inc.
General Hospital · 77d
Cleared Nov 29, 2000
B-D ULTRA-FINE III PEN NEEDLE
K002938 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 69d
Cleared Nov 29, 2000
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K002986 · HQC
A.R.C. Laser AG
Ophthalmic · 65d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · GGM
Bio-Rad
Hematology · 62d
Cleared Nov 29, 2000
FASTPACK CONTROL
K003095 · JJX
Qualigen, Inc.
Immunology · 57d
Cleared Nov 29, 2000
ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50...
K003213 · LYY
Concept Rubber Products Sdn Bhd
General Hospital · 47d
Cleared Nov 29, 2000
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · LAF
Worldwide Medical Corp.
Toxicology · 383d
Cleared Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE...
K002064 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 144d
Cleared Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · LGC
Diamedix Corp.
Microbiology · 126d
Cleared Nov 28, 2000
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · CBI
Cook, Inc.
Anesthesiology · 124d
Cleared Nov 28, 2000
KAVO CORUND HANDPIECE 2013
K002708 · KOJ
Kavo America
Dental · 90d
Cleared Nov 28, 2000
WARTNER WART REMOVAL SYSTEM
K002714 · GEH
Wartner Medical Products
General & Plastic Surgery · 89d
Cleared Nov 28, 2000
SURGI-VISION PROSTATE COIL
K002916 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Nov 28, 2000
ZAP DUAL CURING LIGHT
K002991 · EBZ
Soft-Core Texas, Inc.
Dental · 64d
Cleared Nov 28, 2000
SELF ETCH BONDING PRIMER
K003011 · KLE
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Nov 28, 2000
RENEW LS-2
K003361 · EBF
Bisco, Inc.
Dental · 32d
Cleared Nov 28, 2000
PROCAD ADD-ON
K003373 · EIH
Ivoclar North America, Inc.
Dental · 29d