|
Establishment
Name
|
Registration Number |
Current
Registration Yr |
|
|
3003768277
|
2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Exporter; Manufacturer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
|
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
|
|
|
Manufacturer; Complaint File Establishment
|
|
|
|
|
|
|
|
Foreign Exporter; Manufacturer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
system, nuclear magnetic resonance imaging
-
459801729991 - MICROSCOPY COIL SET, INGENIA 1.5T; 459801730011 - MICROSCOPY COIL SET, INGENIA 3.0T; 459801794481 - MICROSCOPY COIL SET, INGENIA 3.0T; 459801795041- MICROSCOPY COIL SET, INGENIA 1.5T; Achieva R4 1.5T (Ingenia); Achieva R4 3.0T (ingenia); dS MICROSCOPY 23MM COIL, INGENIA 1.5T; dS MICROSCOPY 23MM COIL, INGENIA 3.0T; dS MICROSCOPY 47MM COIL, INGENIA 1.5T; dS MICROSCOPY 47MM COIL, INGENIA 3.0T; Ingenia 1.5T; Ingenia 3.0T; Ingenia CX 1.5T; Ingenia CX 3.0T; wBTS Sensor Set, ECG 1.0 meter - 98980319364X; wBTS wPPU Sensor Accessories - 98980319363X; wBTU PPU + RESP Module - 98980319445X; wBTU VCG Module - 98980319444X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Exporter; Manufacturer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
monitor, physiological, patient (without arrhythmia detection or alarms)
-
ADVANCED FILTER ECG CABLE - 989803170121; Anesthetic Oxygen (O2) Sensor - 989803162051; CAB,4 LD,CV MRI ECG - 9223; CAB,4 LD,MRI ECG - 9224; CAB,4 LD,NEO.MRI ECG - 9222; Cable, Digital Gating, GE - 9292; Cable, Digitial Gating, Hitachi / Toshiba - 9293; Cuff, Infant, MRI, Colder Conn - 989803169431; CUFF,ADULT,MRI,COLDER CONN - 989803169451; CUFF,LARGE ADULT,MRI,COLDER CONN - 989803169461; CUFFF,CHILD,MRI,COLDER CONN - 989803169441; Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421; Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401; Expression MR KIT,ACCESSORIES,NIBP,MRI - 94014; Expression MR KIT,DISPOSABLE WATER TRAP,3160 - 94012; Expression MR KIT,STARTER,AGENTS,3160 - 94019; Expression MR KIT,STARTER,ETCO2,3160 - 94022; Expression MR KIT,WATER TRAP,ETCO2,3160 - 94020; Expression MRI Patient Monitoring System (Model 865214); GATING CABLE, SIEMENS - 9291; GRIP SENSOR STARTER KIT - 989803162491; Kit, Sample, ETCO2, 3160 - 94021; KIT,SAMPLE,AGENTS,3160 - 94018; KIT,STARTER,NEONATAL,MRI - 94013; KIT,STARTER,QUADTRODE CV - 94015; KIT,STARTER,STANDARD ECG - 94016; MRI Patient Monitoring System, Mode; NiBP, Disp, Adult Extra-Long, 27 - 36cm - 989803170471; NiBP, Disp, Adult, 27 - 36cm - 989803170461; NiBP, Disp, Infant, 10 - 15cm - 989803170431; NiBP, Disp, Large Adult, 35 - 45 - 989803170481; NiBP, Disp, Pediatric, 14 - 21cm - 989803170441; NiBP, Disp, Sample kit - 989803170501; NiBP, Disp, Small Adult, 20 - 28cm - 989803170451; NiBP, Disp,Large Adult Extra-Long, 35-45cm - 989803170491; PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023; Precess wECG Patient Module - 989803172441; Quick Connect SpO2 Clip, Adult - 989803166531; Quick Connect SpO2 Clip, Pediatric - 989803166541; Quick Connect SpO2 Grip, Adult, 20/box - 989803166551; Quick Connect SpO2 Grip, Infant, 20/box - 989803166571; Quick Connect SpO2 Grip, Neo, 20/box - 989803166581; Quick Connect SpO2 Grip, Ped, 20/box - 989803166561; Quick Connect SpO2 Probe, MRI - 989803161991; Quick Connect SpO2 Starter Kit - 989803167111; SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501; SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511; Wireless ECG Module - 989803163121; Wireless SP02 Module (Gen 2) - 989803163111
|
|
-
monitor, physiological, patient (without arrhythmia detection or alarms)
-
Adult Pressure Interconnect Hose - 989803183221; Advanced Apps ECG Cable - 989803176381; Expression IP5 Information Portal; Expression IP5 Software Upgrade - 989803197491; Expression MR Wireless ECG Patient Module - 989803183661; Expression MR200 MRI Patient Monitoring System; Expression MR200 New MRI Monitor Accessories - 866177; Neonatal Pressure Interconnect Hose - 989803183231; NiBP Cuff, Single Lumen, Adult - 989803182641; NiBP Cuff, Single Lumen, Adult, Disp - 989803182541; NiBP Cuff, Single Lumen, Adult-L - 989803182651; NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551; NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211; NiBP Cuff, Single Lumen, Infant - 989803182611; NiBP Cuff, Single Lumen, Infant, Disp - 989803182511; NiBP Cuff, Single Lumen, Lrg Adult - 989803182661; NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561; NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671; NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171; NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181; NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191; NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201; NiBP Cuff, Single Lumen, Pediatric - 989803182621; NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521; NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591; NiBP Cuff, Single Lumen, Small Adult - 989803182631; NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531; NiBP Cuff, Single Lumen, Thigh - 989803182681; NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581; NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571; Wireless SpO2 Patient Module - 989803183541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
coil, magnetic resonance, specialty
-
459801729901 - dS Breast 7ch 1.5T; 459801729911 - dS Breast 7ch 3.0T; Biopsy Breast Coil; Coil/ASM/Breast Coil for Echelon; dS Breast 16ch 1.5T; Fiducial Holder, Needle Hub Assembly,; GE Excite 1.5T 7CH BBC; GE Excite 1.5T 7Ch Biopsy Breast Array; GE Excite HDx 1.5T 7ch BBC; GE Excite HDx 1.5T HDx 7CH BBC; GE HDx 3.0T 7Ch Biopsy Breast; GE LBS 1.5T16CH; GE LBS 3.0T 16CH; GE LBS 3.0T 7CH; Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate,; Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder,; HITACHI 1.5T 7C BREAST; LBS 3.0T SMS 7 ch; MammoTrak Interventional Breast Coil 1.5T; Philip Interventional Coil 3.0T, PHC, Achieva TX; PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC; Philips 7ch SENSE Breast Coil 1.5T; Philips dS Breast 7ch 1.5T; Philips dS Breast 7ch 3.0T; Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil); Siemens AVANTO 1.5T BBC; Siemens Luminescence 1.5T Breast Coil 16 Ch; Siemens Luminescence 1.5T Breast Coil 7 Ch; Siemens Luminescence 3.0T Breast Coil 16 Ch; Siemens SYMPHONY 1.5T BBC; Toshiba 1.5T 7CH BBC
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
coil, magnetic resonance, specialty
-
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS; dS Anterior Coil (1.5T); dS Anterior Coil (3.0T), dS Base Coil (1.5T), dS Base Coil (3.0T), dS Head-Neck Coil (1.5T); dS Flex Coil L (3.0T); dS Flex Coil S (3.0T), dS Flex Coil M (1.5T), dS Flex Coil M (3.0T), dS Flex Coil L (1.5T); dS Head-Neck Coil (3.0T), dS Head Coil (1.5T), dS Head Coil (3.0T), dS Flex Coil S (1.5T); FRU, COIL ASSY, PHC 1.5T 16CH
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
guide, needle, surgical
-
INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS; INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM; INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM; INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand; INVIVO (SCHWERIN, GERMANY): GRID PLATE ENHANCED ACCESS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
Complaint File Establishment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
Manufacturer; Specification Developer
|
|
|
|
|
![Sort by Establishment Name [A-Z]](/scripts/cdrh/images/arrow_up-black.GIF){kind=icon}
![Sort by Establishment Name [Z-A]](/scripts/cdrh/images/arrow_down-black.GIF){kind=icon}
