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
80281–80304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2000
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
K003429 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 30, 2000
DISPOSABLE PRESSURE MONITOR
K003497 · CAP
Engineered Medical Systems
Anesthesiology · 17d
Cleared Nov 29, 2000
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · DYB
Daig Corp.
Cardiovascular · 331d
Cleared Nov 29, 2000
SENSAIRE DIAGNOSTIC SPIROMETER
K001278 · BZG
Qrs Diagnostic, LLC
Anesthesiology · 222d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · LIP
Trinity Biotech, Plc
Microbiology · 197d
Cleared Nov 29, 2000
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
K002010 · DJR
OraSure Technologies, Inc.
Toxicology · 149d
Cleared Nov 29, 2000
DELTA 32 AND DELTA 32 TACT
K002472 · IZH
Instrumentarium Imaging, Inc.
Radiology · 110d
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