FDA.reportPublic FDA data

NextPhase Medical Devices LLC

Matched from indexed company URL: NextPhase Medical Devices

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12254923001237338NextPhase Medical Devices LLC1N2026-01-0188 Airport Dr ROCHESTER NH US 03867
30031742843003174284NextPhase Medical Devices, LLC1N2026-01-01110 FORBES BLVD. MANSFIELD MA US 02048
30071997403007199740NextPhase Medical Devices1N2020-04-25150 Hopper Ave Waldwick NJ US 07463

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859758005009Sontek Medical - Suction Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com
00859758005023Sontek Medical - Bronch Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com
00859758005047Sontek Medical - Bronch Safe™ Swivel Y508-261-0800lsampson@nextphasemed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
524611442873347K983112RESPIRATORY HUMIDIFIER, MODEL # MR850BTT1998-11-10
524611648620477K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSCCL1998-03-30
524611229586531K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
1219581070230506K882048MEDITRON ENDOLAV MODEL EL-100KNS1988-10-31
1219581096629224K190160neXus Ultrasonic Surgical Aspirator SystemLFL2019-05-30
524611632185944K181170Trilogy Evo UniversalCBK2019-07-18
524611566518665K181166Trilogy EvoCBK2019-07-18
207361358397267K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesGEI2018-01-17
207361066319858K162332Nexcore GI InsufflatorFCX2016-09-29
1219582071169292K162332Nexcore GI InsufflatorFCX2016-09-29
524611582993763K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitBTT2015-03-05
524612034401318K141833STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATIONHAW2015-03-25
524611350032219K133665MALLEABLE SUCTION INSTRUMENTSPGW2014-03-13
524611300617221K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
524611533549472K122432ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITSBZE2012-12-06
524611929994072K120819STALIF COVE2012-08-31
524611689162280K111732AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALERGEI2011-12-05
524611317230238K103767DUAL HEATED INFANT VREATHING CIROUITSBZE2012-04-16
524611714009337K101301STALIF MIDLINEMAX2010-09-24
1219581612139593K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICEHRX2009-08-03
524611315872505K073495TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHTGEI2008-01-09
524611222490168K063639AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1GEI2007-02-22
524611459373167K052859AQUAMANTYS PUMP GENERATOR SYSTEMGEI2005-10-25
524611591954981K050438STEALTHSTATION SYSTEM UPDATEHAW2005-06-02
1219581438582249K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475HRX2003-03-20
1219581853535895K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005GCJ2000-12-22
524611089301357K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEMHAW2000-06-12
1219581026080736DEN170091EyeBOXQEA2018-12-28
524611135435963
1219581557308412
524611694713595
524611904543739
524611019566395
524611089301357
207361160639976
524611190948223
524611229586531
207361253815174
207361265603909
207361273235414
524611290145164
524611300617221
207361311193707
524611315872505
524611334098082
524611350032219
524611381990975
207361401092689
524611459373167
524611466327540
524611471734297
207361563958757
524611591954981
524611632564928
524611652570347
207361664410709
524611740129454
524611839912800
207361898480852
524611916595991
524611945544925
524612034401318
524612048812900

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI52018-01-17
HAW42015-03-25
CBK22019-07-18
FCX22016-09-29
BTT22015-03-05
BZE22012-12-06
HRX22009-08-03
LFL12019-05-30
QEA12018-12-28
PGW12014-03-13
OLO12013-08-14
OVE12012-08-31
MAX12010-09-24
GCJ12000-12-22
CCL11998-03-30
KNS11988-10-31

GUDID#