Heraeus Medical G M B H

FDA Filings

This page includes the latest FDA filings for Heraeus Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006406161
• FEI Number: 3006406161
• Name: Heraeus Medical GmbH
• Owner & Operator: Heraeus Medical GmbH
• Contact Address: Philipp-Reis-Str. 8/13 ; Wehrheim DE-HE Hessen 61273 DE
• Official Correspondent:
  • Yannick N Hermanns
  • 49-6181-35-2818
• US Agent:
  • Gordon MacFarlane
  • ICONplc
  • 919 8738962
  • 215 6996288
  • Gordon.MacFarlane@iconplc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PHILIPP-REIS-STRASSE 8/13 ; WEHRHEIM Hessen, D-61273 DE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3013186738
• FEI Number: 3013186738
• Name: Heraeus Medical LLC
• Owner & Operator: Heraeus Medical GmbH
• Contact Address: Philipp-Reis-Str. 8/13 ; Wehrheim DE-HE Hessen 61273 DE
• Official Correspondent:
  • Yannick N Hermanns
  • 49-6181-35-2818
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: Township Line Road 770, Suite 300 ; Yardley, PA 19067 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 04260102136885 Heraeus Medical GmbH	COPAL® exchange G 5034795	2024-02-16
GUDID 04260102136878 Heraeus Medical GmbH	COPAL® exchange G 5034788	2024-02-16
GUDID 04260102136847 Heraeus Medical GmbH	COPAL® exchange G 5034791	2024-02-16
GUDID 04260102136816 Heraeus Medical GmbH	COPAL® exchange G 5034793	2024-02-16
GUDID 04260102136786 Heraeus Medical GmbH	COPAL® exchange G 5034794	2024-02-16
GUDID 04260102136755 Heraeus Medical GmbH	COPAL® exchange G 5034785	2024-02-16
GUDID 04260102136724 Heraeus Medical GmbH	COPAL® exchange G 5034790	2024-02-16
GUDID 04260102136694 Heraeus Medical GmbH	COPAL® exchange G 5034792	2024-02-16
GUDID 04260102139398 Heraeus Medical GmbH	COPAL® knee mould Trial S US 5159874	2023-07-03
GUDID 04260102139367 Heraeus Medical GmbH	COPAL® knee mould Trial L US 5165924	2023-07-03
GUDID 04260102139336 Heraeus Medical GmbH	COPAL® knee mould Trial M US 5165923	2023-07-03
GUDID 04260102139299 Heraeus Medical GmbH	COPAL® knee moulds 5159870	2023-05-01
GUDID 04260102139275 Heraeus Medical GmbH	COPAL® knee moulds 5159869	2023-05-01
GUDID 04260102139244 Heraeus Medical GmbH	COPAL® knee moulds 5159868	2023-05-01
GUDID 04260102139220 Heraeus Medical GmbH	COPAL® exchange G 5147216	2022-05-23
GUDID 04260102139190 Heraeus Medical GmbH	COPAL® exchange G 5147215	2022-05-23
PMN K220492 Heraeus Medical GmbH	COPAL Exchange G Hip Spacer	2022-03-23
GUDID 04260102135376 Heraeus Medical GmbH	PALACOS® 5150635	2022-02-21
GUDID 04260102135338 Heraeus Medical GmbH	PALACOS® 5150633	2022-02-21
PMN K213812 Heraeus Medical GmbH	PALACOS MV Pro	2022-02-02
GUDID 04260102136281 Heraeus Medical GmbH	PALACOS® 5081291	2021-07-23
GUDID 04260102136250 Heraeus Medical GmbH	PALACOS® 5081290	2021-07-23
GUDID 04260102136229 Heraeus Medical GmbH	PALACOS® 5081289	2021-07-23
GUDID 04260102136199 Heraeus Medical GmbH	PALACOS® 5081288	2021-07-23
GUDID 04260102136168 Heraeus Medical GmbH	PALACOS® 5081287	2021-07-23
GUDID 04260102136120 Heraeus Medical GmbH	PALACOS® 5081286	2021-07-23
PMN K210607 Heraeus Medical GmbH	PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G Pro	2021-07-09
GUDID 04260102132603 Heraeus Medical GmbH	OSTEOPAL® 66045747	2020-08-18
GUDID 04260102130326 Heraeus Medical GmbH	OSTEOPAL® 66031896	2020-08-18
GUDID 04260102131149 Heraeus Medical GmbH	COPAL® exchange G 5097415	2020-07-15
GUDID 04260102131132 Heraeus Medical GmbH	COPAL® exchange G 5097414	2020-07-15
GUDID 04260102130814 Heraeus Medical GmbH	COPAL® exchange G 5097413	2020-07-15
GUDID 04260102130807 Heraeus Medical GmbH	COPAL® exchange G	2020-07-15
GUDID 04260102130609 Heraeus Medical GmbH	COPAL® exchange G 5092607	2020-07-15
GUDID 04260102136991 Heraeus Medical GmbH	COPAL® exchange G 5034796	2019-12-10
GUDID 04260102136960 Heraeus Medical GmbH	COPAL® exchange G 5034797	2019-12-10
GUDID 04260102136939 Heraeus Medical GmbH	COPAL® exchange G 5034798	2019-12-10
PMN K191016 | KWY Heraeus Medical LLC [Heraeus Medical GmbH]	COPAL? exchange G	2019-11-22
PMN K191016 | KWY Heraeus Medical GmbH	COPAL? exchange G	2019-11-22
PMN K191016 | KWL Heraeus Medical LLC [Heraeus Medical GmbH]	COPAL? exchange G	2019-11-22
PMN K191016 | KWL Heraeus Medical GmbH	COPAL? exchange G	2019-11-22
PMN K191016 | JWH Heraeus Medical LLC [Heraeus Medical GmbH]	COPAL? exchange G	2019-11-22
PMN K191016 | JWH Heraeus Medical GmbH	COPAL? exchange G	2019-11-22
PMN K191016 Heraeus Medical GmbH	COPAL Exchange G Hip And Knee Spacers	2019-11-01
GUDID 04260102136083 Heraeus Medical GmbH	PALACOS® 66057601	2019-06-21
PMN K190766 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? fast R+G	2019-06-03
PMN K190766 | MBB Heraeus Medical GmbH	PALACOS? fast R+G	2019-06-03
PMN K190766 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? fast R+G	2019-06-03
PMN K190766 | LOD Heraeus Medical GmbH	PALACOS? fast R+G	2019-06-03
PMN K190766 Heraeus Medical GmbH	PALACOS Fast R+G	2019-05-31
GUDID 04260102135970 Heraeus Medical GmbH	PALACOS® 5075299	2019-05-13
GUDID 04260102135826 Heraeus Medical GmbH	PALACOS® 5051207	2019-05-13
GUDID 04260102135598 Heraeus Medical GmbH	PALACOS® 5036966	2019-05-13
GUDID 04260102133617 Heraeus Medical GmbH	PALAMIX® 66057897	2019-05-13
GUDID 04260102133587 Heraeus Medical GmbH	PALAMIX® 66057893	2019-05-13
GUDID 04260102132375 Heraeus Medical GmbH	PALAMIX® 66043960	2019-05-13
GUDID 04260102131309 Heraeus Medical GmbH	PALAMIX® 66036747	2019-05-13
GUDID 04260102131170 Heraeus Medical GmbH	PALAMIX® 66036163	2019-05-13
GUDID 04260102136601 Heraeus Medical GmbH	PALACOS® 5087347	2019-05-09
GUDID 04260102133105 Heraeus Medical GmbH	Pro Nozzle short with knee pressurizer	2019-05-06
GUDID 04260102133037 Heraeus Medical GmbH	Pro Nozzle medium	2019-05-06
GUDID 04260102136007 Heraeus Medical GmbH	PALACOS® 5075298	2019-02-21
GUDID 04260102135857 Heraeus Medical GmbH	PALACOS® 5051206	2019-02-21
GUDID 04260102135567 Heraeus Medical GmbH	PALACOS® 5036965	2019-02-21
GUDID 04260102135536 Heraeus Medical GmbH	PALACOS® 5036964	2019-02-21
GUDID 04260102135505 Heraeus Medical GmbH	PALACOS® 5036963	2019-02-21
PMN K182260 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS MV	2018-09-19
PMN K182260 | LOD Heraeus Medical GmbH	PALACOS MV	2018-09-19
PMN K182260 Heraeus Medical GmbH	PALACOS MV	2018-09-17
GUDID B5780011191400115 Heraeus Medical GmbH	PALACOS 00-1119-140-01	2018-07-06
GUDID B5780011181400114 Heraeus Medical GmbH	PALACOS 00-1118-140-01	2018-07-06
GUDID B578001113140011 Heraeus Medical GmbH	PALACOS 00-1113-140-01	2018-07-06
GUDID B578001112140011 Heraeus Medical GmbH	PALACOS 00-1112-140-01	2018-07-06
PMN K153737 | NDN Heraeus Medical LLC [Heraeus Medical GmbH]	OSTEOPAL? plus	2018-02-14
PMN K153737 | NDN Heraeus Medical GmbH	OSTEOPAL? plus	2018-02-14
PMN K153737 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	OSTEOPAL? plus	2018-02-14
PMN K153737 | LOD Heraeus Medical GmbH	OSTEOPAL? plus	2018-02-14
JDZ Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX UNO	2017-12-01
JDZ Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX DUO	2017-12-01
JDZ Heraeus Medical GmbH	PALAMIX UNO	2017-12-01
JDZ Heraeus Medical GmbH	PALAMIX DUO	2017-12-01
JDY Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX vacuum pump	2017-12-01
JDY Heraeus Medical GmbH	PALAMIX vacuum pump	2017-12-01
KIH Heraeus Medical LLC [Heraeus Medical GmbH]	pro nozzle short with knee pressuriser	2017-11-20
KIH Heraeus Medical LLC [Heraeus Medical GmbH]	pro nozzle medium	2017-11-20
KIH Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX Nozzle Slim	2017-11-20
KIH Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX Nozzle Medium	2017-11-20
KIH Heraeus Medical LLC [Heraeus Medical GmbH]	PALAMIX Cement Gun	2017-11-20
KIH Heraeus Medical GmbH	pro nozzle short with knee pressuriser	2017-11-20
KIH Heraeus Medical GmbH	pro nozzle medium	2017-11-20
KIH Heraeus Medical GmbH	PALAMIX Nozzle Slim	2017-11-20
KIH Heraeus Medical GmbH	PALAMIX Nozzle Medium	2017-11-20
KIH Heraeus Medical GmbH	PALAMIX Cement Gun	2017-11-20
PMN K153737 HERAEUS MEDICAL GMBH	OSTEOPAL Plus	2016-04-22
PMN K150119 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS R pro	2015-08-27
PMN K150119 | LOD Heraeus Medical GmbH	PALACOS R pro	2015-08-27
PMN K150119 | KIH Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS R pro	2015-08-27
PMN K150119 | KIH Heraeus Medical GmbH	PALACOS R pro	2015-08-27
PMN K150119 | JDZ Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS R pro	2015-08-27
PMN K150119 | JDZ Heraeus Medical GmbH	PALACOS R pro	2015-08-27
PMN K150119 HERAEUS MEDICAL GMBH	PALACOS R Pro	2015-06-17
PMN K142157 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G pro	2015-01-13
PMN K142157 | MBB Heraeus Medical GmbH	PALACOS? R+G pro	2015-01-13
PMN K142157 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G pro	2015-01-13
PMN K142157 | LOD Heraeus Medical GmbH	PALACOS? R+G pro	2015-01-13
PMN K142157 | KIH Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G pro	2015-01-13
PMN K142157 | KIH Heraeus Medical GmbH	PALACOS? R+G pro	2015-01-13
PMN K142157 | JDZ Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G pro	2015-01-13
PMN K142157 | JDZ Heraeus Medical GmbH	PALACOS? R+G pro	2015-01-13
PMN K031673 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	Palacos G	2015-01-13
PMN K031673 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G	2015-01-13
PMN K031673 | MBB Heraeus Medical GmbH	Palacos G	2015-01-13
PMN K031673 | MBB Heraeus Medical GmbH	PALACOS? R+G	2015-01-13
PMN K031673 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palacos G	2015-01-13
PMN K031673 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? R+G	2015-01-13
PMN K031673 | LOD Heraeus Medical GmbH	Palacos G	2015-01-13
PMN K031673 | LOD Heraeus Medical GmbH	PALACOS? R+G	2015-01-13
PMN K050855 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	Palamed? G	2015-01-12
PMN K050855 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? MV+G	2015-01-12
PMN K050855 | MBB Heraeus Medical GmbH	Palamed? G	2015-01-12
PMN K050855 | MBB Heraeus Medical GmbH	PALACOS? MV+G	2015-01-12
PMN K050855 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palamed? G	2015-01-12
PMN K050855 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? MV+G	2015-01-12
PMN K050855 | LOD Heraeus Medical GmbH	Palamed? G	2015-01-12
PMN K050855 | LOD Heraeus Medical GmbH	PALACOS? MV+G	2015-01-12
PMN K050854 | MBB Heraeus Medical LLC [Heraeus Medical GmbH]	Palacos LV? + G	2015-01-12
PMN K050854 | MBB Heraeus Medical GmbH	Palacos LV? + G	2015-01-12
PMN K050854 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palacos LV? + G	2015-01-12
PMN K050854 | LOD Heraeus Medical GmbH	Palacos LV? + G	2015-01-12
PMN K050085 | NDN Heraeus Medical LLC [Heraeus Medical GmbH]	Osteopal? V	2015-01-12
PMN K050085 | NDN Heraeus Medical GmbH	Osteopal? V	2015-01-12
PMN K050085 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Osteopal? V	2015-01-12
PMN K050085 | LOD Heraeus Medical GmbH	Osteopal? V	2015-01-12
PMN K030904 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palamed?	2015-01-12
PMN K030904 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? MV	2015-01-12
PMN K030904 | LOD Heraeus Medical GmbH	Palamed?	2015-01-12
PMN K030904 | LOD Heraeus Medical GmbH	PALACOS? MV	2015-01-12
PMN K030903 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	PALACOS? LV	2015-01-12
PMN K030903 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Osteopal?	2015-01-12
PMN K030903 | LOD Heraeus Medical GmbH	PALACOS? LV	2015-01-12
PMN K030903 | LOD Heraeus Medical GmbH	Osteopal?	2015-01-12
PMN K030902 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palacos? R	2015-01-12
PMN K030902 | LOD Heraeus Medical GmbH	Palacos? R	2015-01-12
PMN K022251 | LOD Heraeus Medical LLC [Heraeus Medical GmbH]	Palabond?	2015-01-12
PMN K022251 | LOD Heraeus Medical GmbH	Palabond?	2015-01-12
PMN K142157 HERAEUS MEDICAL GMBH	PALACOS R+G PRO	2014-09-05

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Related Finance Registrations

NCAGE Code	CH122	HERAEUS MEDICAL GMBH
CAGE Code	CH122	HERAEUS MEDICAL GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092637073	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	KNOCHENZEMENT-CHILLED LOW VALUE PHA	21 PKG
2020092430301	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	KNOCHENZEMENT-CHILLED LOW VALUE PHA	21 PKG
202009239787	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	PALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II	22 PKG
2020091524924	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	PALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II	22 PKG
2020091033143	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	PALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II	22 PKG
2020082734907	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	KNOCHENZEMENT-CHILLED LOW VALUE PHA	23 PKG
2020061219473	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	KNOCHENZEMENT-CHILLED LOW VALUE PHA	24 PKG
2020061023531	Bremerhaven,Federal Republic of Germany -> New Orleans, Louisiana	KNOCHENZEMENT-CHILLED LOW VALUE PHA	24 PKG