Philips Medical Systems International BV

Entity profile compiled from public source records

Public Record Profile Registrations: 77 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000126901, 1000185293, 1000520785, 1000524572, 1000582314, 1051786, 1218950, 1219324, 2518422, 2518586, 2939520, 3000126629, 3000976525, 3001400310, 3002797442, 3002807167, 3002807880, 3003584029, 3003630387, 3003630806, 3003687189, 3003768251, 3004961434, 3005403518, 3005462046, 3006303679, 3006648320, 3007220521, 3007284006, 3007601164, 3008363989, 3008514395, 3008581796, 3008773647, 3009490946, 3009529630, 3010047475, 3010359222, 3010656400, 3010685285, 3012027770, 3012528160, 3012563754, 3012607778, 3012938564, 3014128039, 3014541700, 3015763655, 3015777306, 3016257349, 3016618143, 3016701404, 3016812424, 3016851825, 3017403359, 3017654247, 3017894900, 3018004899, 3019216, 3023385454, 3027553886, 3029227324, 3033525986, 3033525987, 3033526676, 3033527241, 3033527273, 3033527281, 3033527282, 3033527283, 3033527770, 3033558564, 3038281851, 3038562397, 3042175841, 3042175844, 3042177665
Owner Operator Numbers 1217116, 2518422, 2939520, 9005541, 9077981
Locations Covered ANDOVER, MA, US; Andover, MA, US; BEST Noord-Brabant, NL; BOEBLINGEN Baden-Wurttemberg, DE; BOTHELL, WA, US; Baner Pune Maharashtra, IN; Bedford, MA, US; Bengaluru Karnataka, IN; Best Noord-Brabant, NL; Blumenau Santa Catarina, BR; Bothell, WA, US; Cambridge, MA, US; Colorado Springs, CO, US; Coyol Alajuela, CR; Drachten Fryslan, NL; EAGAN, MN, US; Eindhoven Noord-Brabant, NL; Export, PA, US; FREMONT, CA, US; Gainesville, FL, US; HAIFA, IL; HAMBURG, DE; Haifa, IL; Herrsching Bavaria, DE; Klagenfurt Karnten, AT; Linwood, PA, US; Lodz Lodzkie, PL; MURRYSVILLE, PA, US; Mississauga Ontario, CA; Mount Pleasant, PA, US; Muka Kuning, Batam Riau, ID; Murrysville, PA, US; New Kensington, PA, US; Ontario, CA, US; Orlando, FL, US; PARIS, FR; Paris, FR; Phoenix, AZ, US; Pimpri Maharashtra, IN; Plymouth, MN, US; Pune Maharashtra, IN; Raanana Central, IL; Ramat Gan Tel Aviv, IL; Rancho Cordova, CA, US; Reedsville, PA, US; SHANGHAI, CN; SHENZHEN Guangdong, CN; San Diego, CA, US; Shenyang Liaoning, CN; Shenzhen Guangdong, CN; Suzhou Jiangsu, CN; UNTERSCHLEISSHEIM Bavaria, DE; Varginha Minas Gerais, BR; Woodinville, WA, US; Zhuhai Guangdong, CN

Registered Establishments (77)

Registration # Establishment Name Location Establishment Type(s) Action
1051786 INVIVO CORPORATION Orlando, FL, US Develop Specifications But Do Not Manufacture At This Facility View Details
1218950 Philips North America LLC ANDOVER, MA, US Develop Specifications But Do Not Manufacture At This Facility View Details
1219324 RESPIRONICS NOVAMETRIX, LLC Andover, MA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2031532 DISCUS DENTAL, LLC Ontario, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device View Details
2133409 BRAEMAR MANUFACTURING, LLC EAGAN, MN, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2518422 RESPIRONICS INC. MURRYSVILLE, PA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
2518586 Philips Ultrasound LLC Reedsville, PA, US Manufacture Medical Device View Details
2939520 VOLCANO CORPORATION Rancho Cordova, CA, US Manufacture Medical Device View Details
3000126629 Philips Electronics Ltd Mississauga Ontario, CA Export Device to the United States But Perform No Other Operation on Device View Details
3000976525 Philips Medical Systems Nederland B.V. Eindhoven Noord-Brabant, NL Export Device to the United States But Perform No Other Operation on Device View Details
3001400310 Respironics Deutschland GmbH & Co.KG Herrsching Bavaria, DE Export Device to the United States But Perform No Other Operation on Device View Details
3002797442 RESPIRONICS, INC. Mount Pleasant, PA, US Repack or Relabel Medical Device View Details
3003584029 Braemar Manufacturing, LLC San Diego, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3003630387 Philips France PARIS, FR Develop Specifications But Do Not Manufacture At This Facility View Details
3003630806 Philips Austria GmbH Klagenfurt Karnten, AT Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3003687189 Philips Goldway (Shenzhen) Industrial Inc. SHENZHEN Guangdong, CN Develop Specifications But Do Not Manufacture At This Facility View Details
3003768251 Philips Medical Systems DMC GmbH HAMBURG, DE Complaint File Establishment per 21 CFR 820.198 View Details
3003768277 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details
3005403518 Philips Ultrasound (Shanghai) Co., Ltd SHANGHAI, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3005462046 SPECTRANETICS CORP. FREMONT, CA, US Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198 View Details
3006648320 Philips North America LLC Cambridge, MA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3007220521 RESPIRONICS, INC. New Kensington, PA, US Manufacture Medical Device View Details
3007284006 SPECTRANETICS CORP. Colorado Springs, CO, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3007601164 Philips Consumer Lifestyle B.V. Drachten Fryslan, NL Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3008363989 Volcano Corporation San Diego, CA, US Complaint File Establishment per 21 CFR 820.198 View Details
3008514395 Telcare, LLC Linwood, PA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3008773647 CARDIONET, LLC Phoenix, AZ, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3009490946 Volcano Corporation by Volcarica S.R.L. Coyol Alajuela, CR Manufacture Medical Device View Details
3009529630 Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu, CN Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3010047475 PT PHILIPS INDUSTRIES BATAM Muka Kuning, Batam Riau, ID Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device View Details
3010359222 Philips Consumer Lifestyle B.V. Drachten Fryslan, NL Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3010656400 Philips Medical Systems Technologies Ltd Ramat Gan Tel Aviv, IL Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3010685285 Philips India Limited Pune Maharashtra, IN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3012027770 Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC SHANGHAI, CN Develop Specifications But Do Not Manufacture At This Facility View Details
3012528160 Philips North America LLC Murrysville, PA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3012563754 Philips Medical Systems Nederland B.V. Best Noord-Brabant, NL Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3012607778 Philips North America LLC Woodinville, WA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3012938564 Philips Health Technology (China) Co., Ltd. Shenyang Branch Shenyang Liaoning, CN Develop Specifications But Do Not Manufacture At This Facility View Details
3014128039 Philips Clinical Informatics Blumenau Santa Catarina, BR Manufacture Medical Device View Details
3014541700 Philips Medical Systems Ltda Varginha Minas Gerais, BR Develop Specifications But Do Not Manufacture At This Facility View Details
3015763655 Philips Medical Systems Technologies Ltd. Haifa, IL Export Device to the United States But Perform No Other Operation on Device View Details
3015777306 Philips Medical Systems Nederland B.V. Best Noord-Brabant, NL Develop Specifications But Do Not Manufacture At This Facility View Details
3016257349 Philips Image Guided Therapy Corporation Plymouth, MN, US Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198 View Details
3016618143 Philips North America LLC Cambridge, MA, US Complaint File Establishment per 21 CFR 820.198 View Details
3016701404 Philips North America LLC Export, PA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3016812424 CARDIONET, LLC Linwood, PA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3016851825 Philips Global Business Services LLP Pune Maharashtra, IN Manufacture Medical Device View Details
3017403359 Philips DAP Care Company of Zhuhai SEZ Limited Zhuhai Guangdong, CN Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3017654247 SPECTRAWAVE, INC. Bedford, MA, US Manufacture Medical Device View Details
3017894900 Philips Ultrasound LLC Cambridge, MA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3018004899 Philips Medical Systems (Cleveland), Inc. Gainesville, FL, US Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details
3019216 Philips Ultrasound LLC BOTHELL, WA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3023385454 Philips DS North America LLC Gainesville, FL, US Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details
3026630 PHILIPS ORAL HEALTHCARE, LLC Bothell, WA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3027553886 Respironics, Inc. Coyol Alajuela, CR Manufacture Medical Device View Details
3029227324 Philips Global Business Services LLP Baner Pune Maharashtra, IN Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3030677 Philips North America LLC Bothell, WA, US Manufacture Medical Device View Details
3033525986 Philips India Limited - Diagnostic X-ray Business Unit Pimpri Maharashtra, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033525987 Philips India Limited - Image Guided Therapy Systems Business Unit Pune Maharashtra, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033526676 Philips India Limited - Sleep & Respiratory Care Business Unit Bengaluru Karnataka, IN Manufacture Medical Device View Details
3033527241 Philips Global Business Services LLP - Ultrasound Business Unit Baner Pune Maharashtra, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033527273 Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units Bengaluru Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033527281 Philips India Limited - Magnetic Resonance Business Unit Bengaluru Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033527282 Philips India Limited - Image Guided Therapy Systems Business Unit Bengaluru Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033527283 Philips India Limited - Ultrasound Business Unit Bengaluru Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033527770 Philips India Limited - Diagnostic X-ray Business Unit Bengaluru Karnataka, IN Develop Specifications But Do Not Manufacture At This Facility View Details
3033558564 PHILIPS FRANCE Paris, FR Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL Export Device to the United States But Perform No Other Operation on Device View Details
3038562397 Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL Develop Specifications But Do Not Manufacture At This Facility View Details
3042175844 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3042177665 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL Complaint File Establishment per 21 CFR 820.198 View Details
8043836 TOMTEC Imaging Systems GMBH UNTERSCHLEISSHEIM Bavaria, DE Manufacture Medical Device View Details
9610816 Philips Medizin Systeme Boeblingen GmbH BOEBLINGEN Baden-Wurttemberg, DE Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
9617978 PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. HAIFA, IL Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
9681475 Philips Medical Systems Technologies Ltd. Raanana Central, IL Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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