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
81361–81384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · KWI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · HSD
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 27, 2000
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
K001527 · GEX
Fotona D.D.
General & Plastic Surgery · 72d
Cleared Jul 27, 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 71d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · FOZ
Abbott Laboratories
General Hospital · 63d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS...
K001739 · LYY
Allegiance Healthcare Corp.
General Hospital · 49d
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