Company ยท US
Zoll Medical Corporation, World Wide Headquarters
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2015. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2015 | K133239 | ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| May 22, 2014 | K133269 | ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Oct 26, 2012 | K120406 | ZOLL FULLY AUTOMATIC AED PLUS Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Sep 25, 2012 | K120907 | ZOLL R SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 25, 2012 | K112761 | ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Mar 21, 2012 | K112432 | ZOLL X SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Oct 27, 2011 | K111296 | ZOLL RESCUENETLINK Zoll Medical Corporation, World Wide Headquarters | MSX |
| Aug 17, 2011 | K111594 | ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Mar 8, 2011 | K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 17, 2011 | K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Feb 17, 2011 | K110154 | ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Sep 30, 2010 | K102468 | ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters | LDD |
| Sep 15, 2010 | K102174 | ZOLL PROPAQ M Zoll Medical Corporation, World Wide Headquarters | DRT |
| Jul 29, 2010 | K100654 | ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters | LDD |
| Dec 23, 2009 | K091265 | ZOLL E SERIES WITH CPRREADYCHARGE Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Dec 3, 2009 | K092598 | ZOLL E SERIES WITH SPCO/SPMET OPTION Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Mar 9, 2009 | K081081 | ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 24, 2008 | K072923 | ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 23, 2008 | K080232 | ZOLL E SERIES 12SL, ANALYSIS OPTION Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Jun 22, 2007 | K071025 | ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO Zoll Medical Corporation, World Wide Headquarters | MKJ |
| Apr 26, 2007 | K070455 | ZOLL E SERIES WITH SEE-THRU CPR Zoll Medical Corporation, World Wide Headquarters | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2010 | ZOLL Medical Corporation, World Wide Headquarters ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA.
Intended for the purpose of converting ventricular fi Terminated |
MKJ | K042007 |
| Sep 29, 2009 | ZOLL Medical Corporation, World Wide Headquarters ZOLL R Series Defibrillator/Pacemaker/Monitor
Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing Terminated |
MKJ | K060559 |
| Apr 1, 2009 | ZOLL Medical Corporation, World Wide Headquarters Zoll AED Plus Defibrillator Terminated |
MKJ | K033474 |
| Jun 28, 2008 | ZOLL Medical Corporation, World Wide Headquarters Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824. Terminated |
MKJ | K042007 |