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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68929–68952 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2004
HERO 1, MODEL LY-ESB220
K031621 · IPL
Comfort Orthopedic Co., Ltd.
Physical Medicine · 244d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · KWL
Exactech, Inc.
Orthopedic · 220d
Cleared Jan 22, 2004
POWERSTAND STAND-UP WHEELCHAIR
K032101 · IPL
The Standing Co., Inc.
Physical Medicine · 198d
Cleared Jan 22, 2004
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
K032692 · JZG
Dako A/S
Immunology · 142d
Cleared Jan 22, 2004
SUNPEX TECHNOLOGIES MODEL SE03
K033019 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 118d
Cleared Jan 22, 2004
T.S. MEDICAL CIRCUMCISION CLAMP
K033403 · HFX
T.S. Medical
Obstetrics & Gynecology · 90d
Cleared Jan 22, 2004
HUBERPRO SAFETY HUBER INFUSION SET
K033515 · FPA
Command Medical Products
General Hospital · 77d
Cleared Jan 22, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
K033835 · LYZ
Mdm Enterprise Corp.
General Hospital · 43d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Dade Behring, Inc.
Chemistry · 36d
Cleared Jan 22, 2004
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
K033982 · MMW
Vysis
Immunology · 30d
Cleared Jan 22, 2004
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
K033989 · DQY
Medtronic Inc. Cardiac Rhythm Management
Cardiovascular · 30d
Cleared Jan 22, 2004
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
K033991 · HIF
Pall Medical
Obstetrics & Gynecology · 30d
Cleared Jan 22, 2004
CA-1500
K040028 · LLZ
R2 Technology, Inc.
Radiology · 14d
Cleared Jan 21, 2004
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
K031321 · KMF
Medlogic Global Limited
General & Plastic Surgery · 271d
Cleared Jan 21, 2004
AEROMIST LT, MODEL HCS15004
K031686 · BTI
Medline Industries, Inc.
Anesthesiology · 233d
Cleared Jan 21, 2004
SK MED ME202 MONITORING MIXER
K031860 · BZR
Sk Med
Anesthesiology · 219d
Cleared Jan 21, 2004
INTUITION IMAGE
K032511 · LHN
Brainlab AG
Radiology · 160d
Cleared Jan 21, 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · GEX
Cynosure, Inc.
General & Plastic Surgery · 112d
Cleared Jan 21, 2004
AMERSHAM HEALTH NEEDLE-GUARD
K033409 · FMI
Gettig Pharmaceutical Instrument Co.
General Hospital · 89d
Cleared Jan 21, 2004
VARIFLEX
K033632 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 63d
Cleared Jan 21, 2004
IDEIA PCE CHLAMYDIA
K033865 · LJC
Dakocytomation, Ltd.
Microbiology · 40d
Cleared Jan 21, 2004
POLY PER-Q-CATH PICC CATHETERS
K034019 · LJS
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
GROSHONG NXT PICC CATHETERS
K034020 · LJS
C.R. Bard, Inc.
General Hospital · 28d
Cleared Jan 21, 2004
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
K034031 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 23d