FDA 510(k) Applications Submitted by Mary Kruitwagen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120132 |
01/17/2012 |
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS |
| K210252 |
01/29/2021 |
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System |
Conformis Inc. |
| K080495 |
02/22/2008 |
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 |
PHILIPS MEDICAL SYSTEMS |
| K210809 |
03/17/2021 |
iTotal« IdentityÖ Cruciate Retaining (CR) Knee Replacement System (KRS) |
Conformis, Inc. |
| K110803 |
03/23/2011 |
SURESIGNS VSI VITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS |
| K230844 |
03/28/2023 |
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert |
Conformis Inc. |
| K160951 |
04/05/2016 |
Philips Efficia CMS200 Central Monitoring System |
PHILIPS MEDICAL SYSTEMS |
| K131032 |
04/12/2013 |
PHILIPS SURESIGNS CENTRAL |
PHILIPS MEDICAL SYSTEMS |
| K221104 |
04/14/2022 |
ActeraÖ hip system |
Conformis Inc. |
| K231178 |
04/26/2023 |
ACTERAÖ hip system |
Conformis Inc |
| K221404 |
05/16/2022 |
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) |
Conformis Inc. |
| K151812 |
07/02/2015 |
PATIENT MONITORS VARIOUS MODELS |
PHILIPS MEDICAL SYSTEMS |
| K082280 |
08/11/2008 |
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
| K232426 |
08/11/2023 |
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts |
Conformis Inc |
| K152363 |
08/20/2015 |
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M |
PHILIPS MEDICAL SYSTEMS |
| K112652 |
09/12/2011 |
SURESIGNS VS2+ -SURESIGNS VSI |
PHILIPS MEDICAL SYSTEMS |
| K223316 |
10/28/2022 |
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System |
Conformis Inc. |
| K203421 |
11/20/2020 |
Triathlon AS-1 |
Conformis Inc. |
| K203447 |
11/23/2020 |
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement |
Conformis Inc. |
| K123900 |
12/18/2012 |
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 |
PHILIPS MEDICAL SYSTEMS |
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