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
80785–80808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2001
ASSERACHROM HPIA TEST KIT
K003767 · LCO
Diagnostica Stago, Inc.
Hematology · 68d
Cleared Feb 12, 2001
TOTAL BILIRUBIN
K003829 · CIG
Jas Diagnostics, Inc.
Chemistry · 63d
Cleared Feb 12, 2001
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · MVO
Phamatech
Toxicology · 61d
Cleared Feb 12, 2001
VORTEX ACCESS SYSTEM
K010189 · LJT
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Feb 12, 2001
MXR-2000 MOBILE X-RAY UNIT
K010304 · IZL
Irom Imaging, Inc.
Radiology · 11d
Cleared Feb 09, 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · LYC
Biomet, Inc.
Dental · 88d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499 · LEL
Respironics, Inc.
Neurology · 88d
Cleared Feb 09, 2001
(DISPOSABLE) VAGINAL SPECULUM
K003540 · HIB
Feminica, Inc.
Obstetrics & Gynecology · 85d
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · MAI
Synthes (Usa)
Orthopedic · 67d
Cleared Feb 09, 2001
AML HIP PROSTHESIS
K003800 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 09, 2001
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
K003985 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 45d
Cleared Feb 09, 2001
COSMIC
K010044 · EJT
Jeneric/Pentron, Inc.
Dental · 35d
Cleared Feb 09, 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE...
K010095 · LYY
Sgmp Co., Ltd.
General Hospital · 29d
Cleared Feb 09, 2001
SONIC MODEL SO-300
K010102 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121 · MBI
Synthes (Usa)
Orthopedic · 24d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · GWQ
Excel Tech. , Ltd.
Neurology · 23d
Cleared Feb 09, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · HRX
Ebi, L.P.
Orthopedic · 21d
Cleared Feb 09, 2001
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
K010231 · LYY
Jk Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Feb 09, 2001
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
K010282 · LPH
Stelkast Company
Orthopedic · 10d
Cleared Feb 09, 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 452d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Exactech, Inc.
Orthopedic · 322d
Cleared Feb 08, 2001
ORG-9200A
K002068 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 216d
Cleared Feb 08, 2001
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
K002712 · FLL
Saat , Ltd.
General Hospital · 161d