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
82489–82512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · LWJ
Stelkast Company
Orthopedic · 49d
Cleared Jul 27, 2000
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001748 · LLZ
Barco NV Display Systems
Radiology · 49d
Cleared Jul 27, 2000
MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001753 · LLZ
Barco NV Display Systems
Radiology · 49d
Cleared Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049 · LCX
Selfcare, Inc.
Chemistry · 24d
Cleared Jul 27, 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · JDI
Biomet, Inc.
Orthopedic · 15d
Cleared Jul 27, 2000
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · KGO
Ansell Perry
General Hospital · 7d
Cleared Jul 27, 2000
EPI-STAR SURGICAL LASER SYSTER
K990119 · GEX
Nidek, Inc.
General & Plastic Surgery · 561d
Cleared Jul 27, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · DIO
Alfa Scientific Designs, Inc.
Toxicology · 212d
Cleared Jul 26, 2000
DRX HBA1C
K000887 · LCP
Metrika, Inc.
Hematology · 128d
Cleared Jul 26, 2000
GENERIC BLOOD GLUCOSE TEST STRIP
K001092 · CGA
Inbios Intl., Inc.
Chemistry · 113d
Cleared Jul 26, 2000
STACKABLE CAGE SYSTEM
K001340 · MQP
Depuyacromed
Orthopedic · 90d
Cleared Jul 26, 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · KRR
Biomet, Inc.
Orthopedic · 89d
Cleared Jul 26, 2000
RESPIEVENTS, VERSION 4.2
K001369 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 86d
Cleared Jul 26, 2000
SMILIE PC
K001445 · EIA
Julie Alliance
Dental · 79d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466 · MIX
Smith & Nephew, Inc.
Ear, Nose, Throat · 77d
Cleared Jul 26, 2000
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
K001497 · LZA
Multisafe Sdn. Bhd.
General Hospital · 72d
Cleared Jul 26, 2000
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
K001619 · LZA
Multisafe Sdn. Bhd.
General Hospital · 62d
Cleared Jul 26, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
K001836 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 40d
Cleared Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · HAW
Radionics, Inc.
Neurology · 29d
Cleared Jul 26, 2000
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM...
K001959 · KGO
Hartalega Sdn Bhd
General Hospital · 29d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 21d
Cleared Jul 26, 2000
GASTRIC LAVAGE VALVE
K990365 · KNT
T-Med Vac Corporation
Gastroenterology & Urology · 537d
Cleared Jul 25, 2000
MEDSCOPE
K001314 · HEX
All-Pro Imaging Corp.
Obstetrics & Gynecology · 90d