Panels › Cardiovascular › Product code NLF · Class 2
Oximeter, Reprocessed
Regulation 870.2700
0510(k)s in 12 months (27 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NLF
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascent Healthcare Solutions | 1 | 3 |
| Renu Medical, Inc. | 4 | 0 |
| Sterilmed, Inc. | 4 | 0 |
| Clearmedical, Inc. | 3 | 0 |
| Hygia Health Services, Inc. | 3 | 0 |
| Stryker Sustainability Solutions | 3 | 0 |
| Masimo Corporation | 2 | 0 |
| Vanguard Medical Concepts, Inc. | 2 | 0 |
| Datex-Ohmeda | 1 | 0 |
| Midwest Reprocessing Center, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2024 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed R Stryker Sustainability Solutions | NLF |
| Dec 4, 2022 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD Stryker Sustainability Solutions | NLF |
| Mar 8, 2022 | K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor ( Stryker Sustainability Solutions | NLF |
| Jul 22, 2020 | K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Surgical Instrument and Savings Inc (Dba Medline Renewal) | NLF |
| Jul 3, 2019 | K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors Surgical Instrument Service and Savings, Inc. | NLF |
| Nov 16, 2011 | K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE Renu Medical, Inc. | NLF |
| Jul 28, 2011 | K110723 | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS Masimo Corporation | NLF |
| Feb 18, 2011 | K102560 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Oct 7, 2010 | K101280 | MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE Midwest Reprocessing Center, LLC | NLF |
| Nov 3, 2009 | K092368 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Jul 30, 2009 | K083719 | LNCS OXIMETRY SENSORS Masimo Corporation | NLF |
| Feb 6, 2009 | K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO Renu Medical, Inc. | NLF |
| Jul 29, 2008 | K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS Ascent Healthcare Solutions | NLF |
| May 28, 2008 | K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 Hygia Health Services, Inc. | NLF |
| Nov 29, 2007 | K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 Renu Medical, Inc. | NLF |
| May 25, 2007 | K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 Renu Medical, Inc. | NLF |
| Jun 29, 2005 | K042891 | DATEX-OHMEDA OXY-AFR SENSOR Datex-Ohmeda | NLF |
| Jan 6, 2005 | K042316 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS Vanguard Medical Concepts, Inc. | NLF |
| Dec 13, 2004 | K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR Nellcor Puritan Bennett, Inc. | NLF |
| Sep 23, 2004 | K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Sep 10, 2004 | K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N Hygia Health Services, Inc. | NLF |
| Aug 1, 2003 | K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II Hygia Health Services, Inc. | NLF |
| Mar 28, 2003 | K012677 | REPROCESSED PULSE OXIMETER SENSORS Sterilmed, Inc. | NLF |
| Oct 4, 2002 | K012344 | VANGUARD REPROCESSED PULSE OXIMETER SENSORS Vanguard Medical Concepts, Inc. | NLF |
| Jul 3, 2002 | K012622 | CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 Clearmedical, Inc. | NLF |
| Jul 3, 2002 | K012609 | CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 Clearmedical, Inc. | NLF |
| Jul 3, 2002 | K012600 | CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L Clearmedical, Inc. | NLF |
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