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
81889–81912 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · MRW
Nuvasive, Inc.
Orthopedic · 90d
Cleared Jul 25, 2000
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH...
K001375 · LZA
Best Manufacturing Company
General Hospital · 85d
Cleared Jul 25, 2000
BLAINE SCARCARE PATCH
K001608 · MDA
Blaine Labs, Inc.
General & Plastic Surgery · 62d
Cleared Jul 25, 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · LWJ
Plus Orthopedics
Orthopedic · 29d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · KRO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 25, 2000
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · JDC
Zimmer, Inc.
Orthopedic · 26d
Cleared Jul 25, 2000
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
K002115 · DXN
A&D Engineering, Inc.
Cardiovascular · 12d
Cleared Jul 24, 2000
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580 · MQN
KLS-Martin L.P.
Dental · 153d