FDA.reportPublic FDA data

STERIS ISOMEDIX PUERTO RICO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26486232648623STERIS ISOMEDIX PUERTO RICO, INC.1N2026-01-01KM 1 7, STATE Road, 690 BARRIO SABANA HOYOS Alts De Cerro Gordo 3&4 PR US 00692

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
30041955623856P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
30041403326825K982159ABBOTT PLUM A+ INFUSION PUMPFRN1999-01-12
30041351958061K980503TEMPORARY CARDIAC PACING WIRELDF1998-04-10
30041734237927K973195TOTAL PERFORMANCE SYSTEM SHAVERHRX1997-10-24
30041565761783K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
30041395263239K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACKFQH1997-07-29
30041686021109K963332THERMO-PLASTIC SHAVER BLADESHRX1996-10-11
30041484803172K961122STRYKER KNIFELIGHTFTD1996-08-22
30041416861196K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
30041916187970K941333SE5 ARTHROSCOPY SYTEMHRX1994-11-10
30041157555105K941214LIFESHIELD EXTENSION SETFPK1994-10-03
30041688909730K940697BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCKFPA1994-08-30
30041429107814K934094STRYKER LAPAROSCOPIC SUCTION IRRIGATORGCJ1994-02-18
30041475675381K923915TORQR SERIES DIAGNOSTIC EP CATHETERSDRF1993-02-10
30041902406180K911401ABBOTT LIFECARE 5000 PUMPFRN1991-05-28
30041717142635K904233CONVATEC ABSORBENT BANDAGEEXE1991-03-06
30041288914279K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAK1990-10-26
30041059798327K854077MIX EVAC IIJDZ1986-01-31
30041865018842K841362TIDAL DISTENSION IRRIGATION SETGBX1984-08-02
30042041325262K791774LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRANKPE1979-10-26
30041151180249K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPELKN2012-03-22
30041467793049K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORBRZ2008-03-03
30041279974964K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
30041292508938K050301MRIDIUM 3850 MRI PUMP SYSTEMFRN2005-03-24
30041243134464K041550HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREFRN2004-06-30
30041972140676K041310STRYKER WEDGE SUTURE ANCHOR SYSTEMMBI2004-06-14
30041006043118K033576LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSUREFPA2003-12-04
30041985567478K023062GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENTFRN2002-09-30
30041840391341K011585FAST THERMOMETER MODELS ST713C AND ST713FFLL2001-06-13
30041159244348BP850001
30041837126501BK990009
30041774055958BK980041
30041419403303BK960005
30041037140439BK940040
30041433368039BK120082
30042048228234BK110072
30041038539244BK110066
30041914734707BK090065
30042024047775BK050038
30041100907281BK040059
30041015432732BK020008
30041269048413
30041378838643
30041524600583
30041569471524
30041657536531
30041721870011
30041948875370
30041999159702
30042015876822
30041037873384
30041046248735
30041066936802
30041082342802
30041083546958
30041092770655
30041099630259
30041128429732
30041153955591
30041154441723
30041154653224
30041157765202
30041194242915
30041200160302
30041202506446
30041204096027
30041222342388
30041224494883
30041229987921
30041240117261
30041246552887
30041274913783
30041277774764
30041290950414
30041297151145
30041318470528
30041320762079
30041358289962
30041370131868
30041402388493
30041435836578
30041438219931
30041443150039
30041447232154
30041463565095
30041464106736
30041470019999
30041507260878
30041511429623
30041533625451
30041538306582
30041556105785
30041586483152
30041587948653
30041588843968
30041600025375
30041606742781
30041615072918
30041627477153
30041639791161
30041655044929
30041657379206
30041657570328
30041685728500
30041691311688
30041691483882
30041701606057
30041716645119
30041717285105
30041719282591
30041720464991
30041727584347
30041735636478
30041750318694
30041753820755
30041754013793
30041761629840
30041771992887
30041780886202
30041794692763

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRN52005-03-24
HRX31997-10-24
FPA22003-12-04
LKN12012-03-22
BRZ12008-03-03
NAY12005-04-29
MBI12004-06-14
FLL12001-06-13
LDF11998-04-10
ERL11997-10-01
FQH11997-07-29
FTD11996-08-22
FPK11994-10-03
LXH11994-08-05
GCJ11994-02-18
DRF11993-02-10
EXE11991-03-06
CAK11990-10-26
JDZ11986-01-31
GBX11984-08-02
LWQ11982-12-17
KPE11979-10-26