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 Number3006406161
FEI Number3006406161
NameHeraeus Medical GmbH
Owner & OperatorHeraeus Medical GmbH
Contact AddressPhilipp-Reis-Str. 8/13
Wehrheim DE-HE Hessen 61273 DE
Official Correspondent
  • Yannick N Hermanns
  • 49-6181-35-2818
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPHILIPP-REIS-STRASSE 8/13
WEHRHEIM Hessen, D-61273 DE
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3013186738
FEI Number3013186738
NameHeraeus Medical LLC
Owner & OperatorHeraeus Medical GmbH
Contact AddressPhilipp-Reis-Str. 8/13
Wehrheim DE-HE Hessen 61273 DE
Official Correspondent
  • Yannick N Hermanns
  • 49-6181-35-2818
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration AddressTownship Line Road 770, Suite 300
Yardley, PA 19067 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Heraeus Medical GmbH
COPAL® G+V 51842672024-06-18
Heraeus Medical GmbH
COPAL® exchange G 50347952024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347882024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347912024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347932024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347942024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347852024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347902024-02-16
Heraeus Medical GmbH
COPAL® exchange G 50347922024-02-16
Heraeus Medical GmbH
COPAL® knee mould Trial S US 51598742023-07-03
Heraeus Medical GmbH
COPAL® knee mould Trial L US 51659242023-07-03
Heraeus Medical GmbH
COPAL® knee mould Trial M US 51659232023-07-03
Heraeus Medical GmbH
COPAL® knee moulds 51598702023-05-01
Heraeus Medical GmbH
COPAL® knee moulds 51598692023-05-01
Heraeus Medical GmbH
COPAL® knee moulds 51598682023-05-01
Heraeus Medical GmbH
COPAL® exchange G 51472162022-05-23
Heraeus Medical GmbH
COPAL® exchange G 51472152022-05-23
Heraeus Medical GmbH
COPAL Exchange G Hip Spacer2022-03-23
Heraeus Medical GmbH
PALACOS® 51506352022-02-21
Heraeus Medical GmbH
PALACOS® 51506332022-02-21
Heraeus Medical GmbH
PALACOS MV Pro2022-02-02
Heraeus Medical GmbH
PALACOS® 50812912021-07-23
Heraeus Medical GmbH
PALACOS® 50812902021-07-23
Heraeus Medical GmbH
PALACOS® 50812892021-07-23
Heraeus Medical GmbH
PALACOS® 50812882021-07-23
Heraeus Medical GmbH
PALACOS® 50812872021-07-23
Heraeus Medical GmbH
PALACOS® 50812862021-07-23
Heraeus Medical GmbH
PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G Pro2021-07-09
Heraeus Medical GmbH
OSTEOPAL® 660457472020-08-18
Heraeus Medical GmbH
OSTEOPAL® 660318962020-08-18
Heraeus Medical GmbH
COPAL® exchange G 50974152020-07-15
Heraeus Medical GmbH
COPAL® exchange G 50974142020-07-15
Heraeus Medical GmbH
COPAL® exchange G 50974132020-07-15
Heraeus Medical GmbH
COPAL® exchange G 2020-07-15
Heraeus Medical GmbH
COPAL® exchange G 50926072020-07-15
Heraeus Medical GmbH
COPAL® exchange G 50347962019-12-10
Heraeus Medical GmbH
COPAL® exchange G 50347972019-12-10
Heraeus Medical GmbH
COPAL® exchange G 50347982019-12-10
Heraeus Medical LLC [Heraeus Medical GmbH]
COPAL? exchange G2019-11-22
Heraeus Medical GmbH
COPAL? exchange G2019-11-22
Heraeus Medical LLC [Heraeus Medical GmbH]
COPAL? exchange G2019-11-22
Heraeus Medical GmbH
COPAL? exchange G2019-11-22
Heraeus Medical LLC [Heraeus Medical GmbH]
COPAL? exchange G2019-11-22
Heraeus Medical GmbH
COPAL? exchange G2019-11-22
Heraeus Medical GmbH
COPAL Exchange G Hip And Knee Spacers2019-11-01
Heraeus Medical GmbH
PALACOS® 660576012019-06-21
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? fast R+G2019-06-03
Heraeus Medical GmbH
PALACOS? fast R+G2019-06-03
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? fast R+G2019-06-03
Heraeus Medical GmbH
PALACOS? fast R+G2019-06-03
Heraeus Medical GmbH
PALACOS Fast R+G2019-05-31
Heraeus Medical GmbH
PALACOS® 50752992019-05-13
Heraeus Medical GmbH
PALACOS® 50512072019-05-13
Heraeus Medical GmbH
PALACOS® 50369662019-05-13
Heraeus Medical GmbH
PALAMIX® 660578972019-05-13
Heraeus Medical GmbH
PALAMIX® 660578932019-05-13
Heraeus Medical GmbH
PALAMIX® 660439602019-05-13
Heraeus Medical GmbH
PALAMIX® 660367472019-05-13
Heraeus Medical GmbH
PALAMIX® 660361632019-05-13
Heraeus Medical GmbH
PALACOS® 50873472019-05-09
Heraeus Medical GmbH
Pro Nozzle short with knee pressurizer 2019-05-06
Heraeus Medical GmbH
Pro Nozzle medium 2019-05-06
Heraeus Medical GmbH
PALACOS® 50752982019-02-21
Heraeus Medical GmbH
PALACOS® 50512062019-02-21
Heraeus Medical GmbH
PALACOS® 50369652019-02-21
Heraeus Medical GmbH
PALACOS® 50369642019-02-21
Heraeus Medical GmbH
PALACOS® 50369632019-02-21
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS MV2018-09-19
Heraeus Medical GmbH
PALACOS MV2018-09-19
Heraeus Medical GmbH
PALACOS MV2018-09-17
Heraeus Medical GmbH
PALACOS 00-1119-140-012018-07-06
Heraeus Medical GmbH
PALACOS 00-1118-140-012018-07-06
Heraeus Medical GmbH
PALACOS 00-1113-140-012018-07-06
Heraeus Medical GmbH
PALACOS 00-1112-140-012018-07-06
Heraeus Medical LLC [Heraeus Medical GmbH]
OSTEOPAL? plus2018-02-14
Heraeus Medical GmbH
OSTEOPAL? plus2018-02-14
Heraeus Medical LLC [Heraeus Medical GmbH]
OSTEOPAL? plus2018-02-14
Heraeus Medical GmbH
OSTEOPAL? plus2018-02-14
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX UNO2017-12-01
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX DUO2017-12-01
Heraeus Medical GmbH
PALAMIX UNO2017-12-01
Heraeus Medical GmbH
PALAMIX DUO2017-12-01
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX vacuum pump2017-12-01
Heraeus Medical GmbH
PALAMIX vacuum pump2017-12-01
Heraeus Medical LLC [Heraeus Medical GmbH]
pro nozzle short with knee pressuriser2017-11-20
Heraeus Medical LLC [Heraeus Medical GmbH]
pro nozzle medium2017-11-20
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX Nozzle Slim2017-11-20
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX Nozzle Medium2017-11-20
Heraeus Medical LLC [Heraeus Medical GmbH]
PALAMIX Cement Gun2017-11-20
Heraeus Medical GmbH
pro nozzle short with knee pressuriser2017-11-20
Heraeus Medical GmbH
pro nozzle medium2017-11-20
Heraeus Medical GmbH
PALAMIX Nozzle Slim2017-11-20
Heraeus Medical GmbH
PALAMIX Nozzle Medium2017-11-20
Heraeus Medical GmbH
PALAMIX Cement Gun2017-11-20
HERAEUS MEDICAL GMBH
OSTEOPAL Plus2016-04-22
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS R pro2015-08-27
Heraeus Medical GmbH
PALACOS R pro2015-08-27
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS R pro2015-08-27
Heraeus Medical GmbH
PALACOS R pro2015-08-27
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS R pro2015-08-27
Heraeus Medical GmbH
PALACOS R pro2015-08-27
HERAEUS MEDICAL GMBH
PALACOS R Pro2015-06-17
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G pro2015-01-13
Heraeus Medical GmbH
PALACOS? R+G pro2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G pro2015-01-13
Heraeus Medical GmbH
PALACOS? R+G pro2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G pro2015-01-13
Heraeus Medical GmbH
PALACOS? R+G pro2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G pro2015-01-13
Heraeus Medical GmbH
PALACOS? R+G pro2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
Palacos G2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G2015-01-13
Heraeus Medical GmbH
Palacos G2015-01-13
Heraeus Medical GmbH
PALACOS? R+G2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
Palacos G2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? R+G2015-01-13
Heraeus Medical GmbH
Palacos G2015-01-13
Heraeus Medical GmbH
PALACOS? R+G2015-01-13
Heraeus Medical LLC [Heraeus Medical GmbH]
Palamed? G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? MV+G2015-01-12
Heraeus Medical GmbH
Palamed? G2015-01-12
Heraeus Medical GmbH
PALACOS? MV+G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palamed? G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? MV+G2015-01-12
Heraeus Medical GmbH
Palamed? G2015-01-12
Heraeus Medical GmbH
PALACOS? MV+G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palacos LV? + G2015-01-12
Heraeus Medical GmbH
Palacos LV? + G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palacos LV? + G2015-01-12
Heraeus Medical GmbH
Palacos LV? + G2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Osteopal? V2015-01-12
Heraeus Medical GmbH
Osteopal? V2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Osteopal? V2015-01-12
Heraeus Medical GmbH
Osteopal? V2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palamed?2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? MV2015-01-12
Heraeus Medical GmbH
Palamed?2015-01-12
Heraeus Medical GmbH
PALACOS? MV2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
PALACOS? LV2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Osteopal?2015-01-12
Heraeus Medical GmbH
PALACOS? LV2015-01-12
Heraeus Medical GmbH
Osteopal?2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palacos? R2015-01-12
Heraeus Medical GmbH
Palacos? R2015-01-12
Heraeus Medical LLC [Heraeus Medical GmbH]
Palabond?2015-01-12
Heraeus Medical GmbH
Palabond?2015-01-12
HERAEUS MEDICAL GMBH
PALACOS R+G PRO2014-09-05

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092637073Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaKNOCHENZEMENT-CHILLED LOW VALUE PHA21 PKG
2020092430301Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaKNOCHENZEMENT-CHILLED LOW VALUE PHA21 PKG
202009239787Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaPALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II22 PKG
2020091524924Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaPALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II22 PKG
2020091033143Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaPALACOS R 1X40 USPALACOS R+G 1X40 USHS CODE: 30064000TEMPERATURE:+15 DEGREES CELSIUSDANGE ROUS GOODS=============IMO CLASS: 3UN NO: 124 7PG: II22 PKG
2020082734907Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaKNOCHENZEMENT-CHILLED LOW VALUE PHA23 PKG
2020061219473Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaKNOCHENZEMENT-CHILLED LOW VALUE PHA24 PKG
2020061023531Bremerhaven,Federal Republic of Germany -> New Orleans, LouisianaKNOCHENZEMENT-CHILLED LOW VALUE PHA24 PKG

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