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Philips Healthcare Inc.

148 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardia recall (Z-1280-2010)Philips Healthcare Inc.2010-04-08
French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output mo recall (Z-1281-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output mo recall (Z-1282-2010)Philips Healthcare Inc.2010-04-08
Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to prov recall (Z-1283-2010)Philips Healthcare Inc.2010-04-08
NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output mo recall (Z-1284-2010)Philips Healthcare Inc.2010-04-08
NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output recall (Z-1285-2010)Philips Healthcare Inc.2010-04-08
100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used for recall (Z-1286-2010)Philips Healthcare Inc.2010-04-08
Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product. Intended recall (Z-1287-2010)Philips Healthcare Inc.2010-04-08
Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used for recall (Z-1288-2010)Philips Healthcare Inc.2010-04-08
Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is recall (Z-1289-2010)Philips Healthcare Inc.2010-04-08
Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to provi recall (Z-1290-2010)Philips Healthcare Inc.2010-04-08
REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of th recall (Z-1291-2010)Philips Healthcare Inc.2010-04-08
Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product. Intended use of t recall (Z-1292-2010)Philips Healthcare Inc.2010-04-08
100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The inten recall (Z-1293-2010)Philips Healthcare Inc.2010-04-08
Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors i recall (Z-1294-2010)Philips Healthcare Inc.2010-04-08
100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to provide recall (Z-1295-2010)Philips Healthcare Inc.2010-04-08
Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use is to recall (Z-1296-2010)Philips Healthcare Inc.2010-04-08
Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is to pr recall (Z-1297-2010)Philips Healthcare Inc.2010-04-08
515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-inv recall (Z-1298-2010)Philips Healthcare Inc.2010-04-08
French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide con recall (Z-1299-2010)Philips Healthcare Inc.2010-04-08
100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product. Intended use is to provid recall (Z-1300-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide co recall (Z-1301-2010)Philips Healthcare Inc.2010-04-08
100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to provide recall (Z-1302-2010)Philips Healthcare Inc.2010-04-08
100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use is recall (Z-1303-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product. Intended use is to provide recall (Z-1304-2010)Philips Healthcare Inc.2010-04-08
100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use recall (Z-1305-2010)Philips Healthcare Inc.2010-04-08
515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide contin recall (Z-1306-2010)Philips Healthcare Inc.2010-04-08
515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to provide recall (Z-1307-2010)Philips Healthcare Inc.2010-04-08
100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use i recall (Z-1308-2010)Philips Healthcare Inc.2010-04-08
100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product. Int recall (Z-1309-2010)Philips Healthcare Inc.2010-04-08
Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and Heart recall (Z-1135-2010)Philips Healthcare Inc.2010-03-15
Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Modul recall (Z-0562-2010)Philips Healthcare Inc.2009-12-23
Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A. recall (Z-0549-2010)Philips Healthcare Inc.2009-12-17
Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A. recall (Z-0550-2010)Philips Healthcare Inc.2009-12-17
Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A. recall (Z-0551-2010)Philips Healthcare Inc.2009-12-17
Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A. recall (Z-0552-2010)Philips Healthcare Inc.2009-12-17
IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. In recall (Z-0418-2010)Philips Healthcare Inc.2009-11-24
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedsid recall (Z-0372-2010)Philips Healthcare Inc.2009-11-23
SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to recall (Z-0373-2010)Philips Healthcare Inc.2009-11-23
SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to inc recall (Z-0374-2010)Philips Healthcare Inc.2009-11-23
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use f recall (Z-0003-2010)Philips Healthcare Inc.2009-11-09
HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (Hear recall (Z-1795-2009)Philips Healthcare Inc.2009-07-24
Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data c recall (Z-1654-2009)Philips Healthcare Inc.2009-07-07
Philips Avalon Fetal Monitor FM20; Model Number: M2702A. recall (Z-1478-2009)Philips Healthcare Inc.2009-06-26
Philips Avalon Fetal Monitor FM30; Model Number: M2703A. recall (Z-1479-2009)Philips Healthcare Inc.2009-06-26
HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventric recall (Z-1390-2009)Philips Healthcare Inc.2009-06-02
CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage recall (Z-1436-2009)Philips Healthcare Inc.2009-05-27
HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The d recall (Z-1199-2009)Philips Healthcare Inc.2009-05-19
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Every clearance here is in the API, with alerts when new ones post.