FDA.reportPublic FDA data

Heraeus Medical Components Caribe, Inc.

Matched from indexed company URL: Heraeus Medical LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050290493005029049Heraeus Medical Components Caribe, Inc.1N2026-01-01415 ROAD 693 DORADO PR US 00646
30064061613006406161Heraeus Medical GmbH1N2026-01-01PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse DE D-61273
30089880553008988055HERAEUS MEDICAL COMPONENTS, LLC1Y2026-01-015030 Centerville Road Saint Paul MN US 55127
30131867383013186738Heraeus Medical LLC1Y2026-01-01Township Line Road 770, Suite 300 Yardley PA US 19067
30194030373019403037HERAEUS MEDICAL LLC - BIORESOBABLES1N2026-01-01770 Township Line Rd Ste 300 Yardley PA US 19067
30067227423006722742HERAEUS MEDICAL COMPONENTS, LLC1N2020-04-251350 Energy Lane Suite 100 Saint Paul MN US 55108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3412301098314791K250141Synthecure Synthetic Calcium SulfateMQV2025-05-16
1791621736309943K241674OSTEOPAL® VLOD2024-12-05
2110751736309943K241674OSTEOPAL® VLOD2024-12-05
1791621898073753K234028COPAL® exchange G hip spacer; COPAL® G+VKWL2024-02-15
2110751898073753K234028COPAL® exchange G hip spacer; COPAL® G+VKWL2024-02-15
1791621688540951K220492COPAL exchange G hip spacerKWY2022-03-23
2110751688540951K220492COPAL exchange G hip spacerKWY2022-03-23
1791621216256523K213812PALACOS MV proLOD2022-02-02
2110751216256523K213812PALACOS MV proLOD2022-02-02
2110751549349151K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD2021-07-09
1791621549349151K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD2021-07-09
2110751437353219K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD2020-11-23
1791621437353219K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD2020-11-23
1791621881150784K191016COPAL exchange G Hip and Knee SpacersKWY2019-11-01
2110751881150784K191016COPAL exchange G Hip and Knee SpacersKWY2019-11-01
2321011700832241K190960Nalu Lead Blank (50cm)GZB2019-07-11
1791621997546259K190766PALACOS fast R+GLOD2019-05-31
2110751997546259K190766PALACOS fast R+GLOD2019-05-31
1791621590004918K182260PALACOS MVLOD2018-09-17
2110751590004918K182260PALACOS MVLOD2018-09-17
2361651126885194K173052Heraeus TMW GuidewireDQX2017-10-20
2361651185474215K170664Odyssey Micro CatheterDQY2017-11-09
2110751921597341K153737OSTEOPAL plusLOD2016-04-22
1791621921597341K153737OSTEOPAL plusLOD2016-04-22
2361651545353219K152560Bard Snare Retrieval KitMMX2015-10-23
2361651252678619K150225NovaGold High Performance GuidewireOCY2015-03-16
1791621153754854K150119PALACOS R proLOD2015-06-17
2110751153754854K150119PALACOS R proLOD2015-06-17
2361651255055141K143135Spring Coil GuidewireDQX2015-02-20
2110751138719563K142157PALACOS R+G PROLOD2014-09-05
1791621138719563K142157PALACOS R+G PROLOD2014-09-05
2361651933969143K123439NEO ERCP GUIDEWIREOCY2013-01-03
2361651148009148K101729NEOWIRE PTA/PTCA GUIDEWIREDQX2010-09-23
2361651336326858K070150VASCUPUNCTURE PICC GUIDEWIREDQX2007-02-15
1791621851663477K050855PALAMED GLOD2005-07-07
2110751851663477K050855PALAMED GLOD2005-07-07
1791621128525252K050854PALACOS LV+GLOD2005-07-07
2110751128525252K050854PALACOS LV+GLOD2005-07-07
1791621844906205K050085OSTEOPAL VLOD2005-09-14
2110751844906205K050085OSTEOPAL VLOD2005-09-14
2361651338631880K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREDQX2005-03-01
2361651898711109K040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGDQX2004-04-19
1791621940458230K031673REFOBACIN -PALACOS GLOD2004-05-25
2110751940458230K031673REFOBACIN -PALACOS GLOD2004-05-25
2361651386108489K031652VASCUPUNCTURE PICC GUIDEWIREDQX2003-09-30
1791621814808732K030904PALAMEDLOD2003-09-23
2110751814808732K030904PALAMEDLOD2003-09-23
1791621532185121K030903OSTEOPALLOD2003-09-23
2110751532185121K030903OSTEOPALLOD2003-09-23
1791621107009544K030902PALACOS RLOD2003-09-23
2110751107009544K030902PALACOS RLOD2003-09-23
2110751982465577K022251PALABONDLOD2003-02-26
1791621982465577K022251PALABONDLOD2003-02-26
2361651727145439K012861VASCUPUNCTURE ACCESS WIREDQX2002-02-05
2361651006676719
1791621165556812
2361651385746539
1791621580842194
1791621641736191
2361651028318070
1859461066137886
1859461143544581
2110751165556812
1791621252743000
2110751252743000
1859461326451972
2361651385266687
2361651566091965
2110751580842194
2110751641736191
1859461709377336
2361651850306937
2361651999299014
2361652068864799

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOD462024-12-05
DQX82017-10-20
KWY52022-03-23
KWL22024-02-15
OCY22015-03-16
MQV12025-05-16
GZB12019-07-11
DQY12017-11-09
MMX12015-10-23

PMN#

PALAMED

2003-09-23

Heraeus Medical Gmbh Technology

GUDID#

84 records. Showing 1-40. Next