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
72697–72720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2003
ENDOS AC/ACP
K030185 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 49d
Cleared Mar 11, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-890
K030387 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 34d
Cleared Mar 11, 2003
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
K030476 · DQY
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Mar 11, 2003
MODIFICATION TO VNUS CLOSURE SYSTEM
K030557 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 18d
Cleared Mar 10, 2003
LIFESTENT BILIARY ENDOPROSTHESIS
K023121 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 172d
Cleared Mar 10, 2003
KENDRO HERACELL 240 INCUBATOR
K023465 · MQG
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 146d
Cleared Mar 10, 2003
IRRIGATION SETS
K023808 · LJH
International Medsurg Connection
Gastroenterology & Urology · 116d
Cleared Mar 10, 2003
DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
K024077 · DXN
Zewa, Inc.
Cardiovascular · 90d
Cleared Mar 10, 2003
AIGIS-PLUS
K024135 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
AIGIS-SOFT
K024136 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
AIGIS-SUPER
K024142 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
AIGIS-FINE
K024143 · EJT
Sb Lucius, Inc.
Dental · 84d
Cleared Mar 10, 2003
STRYKERWARE SYSTEM
K024159 · LLZ
Stryker Endoscopy
Radiology · 83d
Cleared Mar 10, 2003
RMO PLASMA CURING LIGHT
K024374 · EBZ
Lokki Lasers Medicaux
Dental · 69d
Cleared Mar 10, 2003
ATAC PAK MAGNESIUM REAGENT
K030010 · JGJ
Elan Diagnostics
Chemistry · 67d
Cleared Mar 10, 2003
FYRELINK
K030242 · LLZ
Mpacs, LLC
Radiology · 46d
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · FGE
Cordis Corp.
Gastroenterology & Urology · 31d
Cleared Mar 10, 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · JAK
GE Medical Systems
Radiology · 28d
Cleared Mar 10, 2003
AMERICAN CATHETER, MODEL W3
K030538 · EZD
Catheter, LLC
Gastroenterology & Urology · 18d
Cleared Mar 07, 2003
IM2001 PULSE OXIMETER
K012706 · DQA
Imagyn Medical Technologies, Inc.
Anesthesiology · 570d
Cleared Mar 07, 2003
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
K022167 · CAC
Pall Corp.
Anesthesiology · 247d
Cleared Mar 07, 2003
TRUEZONE PEAK FLOW METER
K023097 · BZH
Monaghan Medical Corp.
Anesthesiology · 170d
Cleared Mar 07, 2003
XYLOS XCELL ANTIMICROBIAL DRESSING
K024054 · MGQ
Xylos Corporation
General & Plastic Surgery · 88d
Cleared Mar 07, 2003
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
K024061 · GEX
Peregrine Surgical , Ltd.
General & Plastic Surgery · 88d