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
85201–85224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1999
DIGITAL IMAGING SYSTEM (BSR)
K991922 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 01, 1999
PATTON SPECULUM
K991963 · HIB
Patton Medical Corp.
Obstetrics & Gynecology · 83d
Cleared Sep 01, 1999
VANTAGE EXSPECT II
K992078 · KPS
Adac Laboratories
Radiology · 75d
Cleared Sep 01, 1999
C-QUEST
K992103 · OWB
Wuestec Medical, Inc.
Radiology · 71d
Cleared Sep 01, 1999
CORE POUCH
K992190 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 64d
Cleared Sep 01, 1999
REUNITE SCREWS
K992301 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 55d
Cleared Sep 01, 1999
ENDIUS SUCTION/IRRIGATION INSTRUMENT
K992535 · OCX
Endius, Inc.
Gastroenterology & Urology · 34d
Cleared Sep 01, 1999
TM-300 TRACTION SYSTEM
K992545 · ITH
Ito Co., Ltd.
Physical Medicine · 33d
Cleared Sep 01, 1999
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Sep 01, 1999
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992761 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 01, 1999
CERALAS D10 810NM DIODE LASER
K992773 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 14d
Cleared Sep 01, 1999
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
K992808 · DXN
A&D Medical Div.
Cardiovascular · 12d
Cleared Sep 01, 1999
OPTIMAX/ COMPACT 2
K992818 · IXW
Protec GmbH & Co. KG
Radiology · 12d
Cleared Aug 31, 1999
CARD GUARD, MODEL CG-6550
K990478 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 196d
Cleared Aug 31, 1999
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 196d
Cleared Aug 31, 1999
O.B. TAMPON
K990536 · HEB
Personal Products Co.
Obstetrics & Gynecology · 193d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50...
K991777 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
K991778 · LYY
Seltom Pacific Sdn. Bhd.
General Hospital · 98d
Cleared Aug 31, 1999
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
K991904 · FMI
Jms Co., Ltd.
General Hospital · 88d
Cleared Aug 31, 1999
LUMA LIGHT 2000 CURE LIGHT
K992102 · EBF
Lumalite, Inc.
Dental · 71d
Cleared Aug 31, 1999
MEDTRONIC AVE BRIDGE STENT
K992569 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 31, 1999
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K992636 · DXJ
Hewlett-Packard Co.
Cardiovascular · 25d
Cleared Aug 30, 1999
ENDOSONICS TRAK BACK DEVICE
K990271 · DQX
Endosonics Corp.
Cardiovascular · 214d
Cleared Aug 30, 1999
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
K990310 · CAK
Charter Medical, Ltd.
General Hospital · 210d