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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
41809–41832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2013
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
K130280 · DTZ
Terumo Corporation
Cardiovascular · 36d
Cleared Mar 13, 2013
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K130333 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Mar 13, 2013
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR,...
K130359 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Mar 13, 2013
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130493 · DTZ
Terumo Corporation
Cardiovascular · 15d
Cleared Mar 13, 2013
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130520 · DTZ
Ashitaka Factory of Terumo Corp.
Cardiovascular · 13d
Cleared Mar 12, 2013
SOPROCARE
K121685 · NBL
Sopro
Dental · 278d
Cleared Mar 12, 2013
PERKINELMER 226 SAMPLE COLLECTION DEVICES
K121864 · PJC
Perkinelmer, Inc.
Chemistry · 259d
Cleared Mar 12, 2013
GETINGE 400HC-E / SERIES STEAM STERILIZER
K122071 · FLE
Getinge Sourcing, LLC
General Hospital · 239d
Cleared Mar 12, 2013
MEMORY METAL STAPLES, EASYCLIP
K122113 · JDR
Stryker Corp.
Orthopedic · 238d
Cleared Mar 12, 2013
IODOFOAM IODOPHOR FOAM DRESSING
K122634 · FRO
Progressive Wound Care Technologies, LLC
General & Plastic Surgery · 195d
Cleared Mar 12, 2013
RAYSCAN A-EXPERT 3D
K122981 · OAS
Ray Co., Ltd.
Radiology · 169d
Cleared Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345 · MQB
Rayence Co., Ltd.
Radiology · 132d
Cleared Mar 12, 2013
SYNGO, CT BONE READING
K123584 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 111d
Cleared Mar 12, 2013
ZIMMER NEXEL TOTAL ELBOW
K123862 · JDC
Zimmer, Inc.
Orthopedic · 88d
Cleared Mar 12, 2013
S4 SPINAL SYSTEM
K123939 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 82d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153 · MKJ
Philips Medical Systems
Cardiovascular · 49d
Cleared Mar 11, 2013
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · IOR
Otto Bock Healthcare LP
Physical Medicine · 502d
Cleared Mar 11, 2013
CS-MAG II
K121825 · DPS
Biomagnetik-Park GmbH
Cardiovascular · 263d
Cleared Mar 11, 2013
GYNECOLOGY STERILIZATION TRAY
K121904 · KCT
Smith & Nephew Inc., Endoscopy Division
General Hospital · 255d
Cleared Mar 11, 2013
DX-D IMAGING PACKAGE
K122736 · MQB
Agfa Healthcare N.V.
Radiology · 173d
Cleared Mar 11, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 161d
Cleared Mar 11, 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487 · MNH
Gold Standard Orthopaedics, LLC
Orthopedic · 118d
Cleared Mar 11, 2013
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
K123614 · CAF
Trudell Medical Intl.
Anesthesiology · 108d
Cleared Mar 11, 2013
SILEX SACROILIAC JOINT FUSION SYSTEM
K123702 · OUR
X-Spine Systems, Inc.
Orthopedic · 98d