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

153 results for "Codman & Shurtleff, Inc."
1–24 of 153
Search insights Median review: 69d Cleared: 100% Top manufacturer: Codman & Shurtleff, Inc. Lead specialty: Neurology
Cleared Jul 20, 2020
CERENOVUS Large Bore Catheter
K193380 · NRY
Codman & Shurtleff, Inc.
Neurology · 228d
Cleared Nov 08, 2019
CERENOVUS Large Bore Catheter
K191237 · DQY
Codman & Shurtleff, Inc.
Neurology · 184d
Cleared Nov 08, 2017
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit,...
K173192 · GWM
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage...
K172537 · JXG
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · JXG
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Sep 25, 2017
GALAXY G3 Mini Microcoil Delivery System
K171862 · HCG
Codman & Shurtleff, Inc.
Neurology · 95d
Cleared Jul 14, 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18...
K171747 · HCG
Codman & Shurtleff, Inc.
Neurology · 31d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jan 05, 2017
YOGA Microcatheter
K162563 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437 · JXG
Codman & Shurtleff, Inc.
Neurology · 58d
Cleared Aug 19, 2016
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit,...
K153347 · GWM
Codman & Shurtleff, Inc.
Neurology · 273d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481 · GXQ
Codman & Shurtleff, Inc.
Neurology · 60d
Cleared Jun 12, 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH...
K150319 · HCG
Codman & Shurtleff, Inc.
Neurology · 123d
Cleared Feb 19, 2015
Codman Certas Plus Programmable Valve
K143111 · JXG
Medos International SARL
Neurology · 113d
Cleared Dec 24, 2014
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT...
K142429 · HCG
Codman & Shurtleff, Inc.
Neurology · 117d
Cleared Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB,...
K140080 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 100d
Cleared Apr 21, 2014
ENVOY GUIDING CATHETER
K140307 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 73d
Cleared Feb 24, 2014
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT...
K133625 · MOF
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Aug 30, 2013
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · QEW
Codman & Shurtleff, Inc.
Cardiovascular · 38d
Cleared Jan 25, 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT...
K123560 · HCG
Codman & Shurtleff, Inc.
Neurology · 67d
Cleared Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776 · DQX
Codman & Shurtleff, Inc.
Cardiovascular · 57d
Cleared Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · JXG
Codman & Shurtleff, Inc.
Neurology · 17d
Cleared Apr 16, 2012
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · KCT
Codman & Shurtleff, Inc.
General Hospital · 90d
Cleared Apr 04, 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · HCG
Codman & Shurtleff, Inc.
Neurology · 29d