Gebr Brasseler G M B H Co Kg

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006157980
• FEI Number: 3006157980
• Name: KOMET USA LLC
• Owner & Operator: GEBR. BRASSELER GMBH & CO. KG
• Contact Address: 25 TROPHAGENER WEG ; LEMGO DE-NOTA D-32657 DE
• Official Correspondent:
  • Petra Meier
  • 49-5261-701-311
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3042 Southcross Blvd. Suite 101; ROCK HILL, SC 29730 US

• Registration Number: 8010468
• FEI Number: 3002806577
• Name: Imke Lindenbeck
• Owner & Operator: GEBR. BRASSELER GMBH & CO. KG
• Contact Address: 25 TROPHAGENER WEG ; LEMGO DE-NOTA D-32657 DE
• Official Correspondent:
  • Petra Meier
  • 49-5261-701-311
• US Agent:
  • Imke Lindenbeck
  • KOMET USA LLC
  • 803 3231504
  • 803 3231504
  • ilindenbeck@komet-usa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3042 SOUTHCROSS BLVD. SUITE 101; Rock Hill, SC 29730 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 24053613289362 Gebr. Brasseler GmbH & Co. KG	Twist Drill PCTHA402	2024-05-10
GUDID 24053613289317 Gebr. Brasseler GmbH & Co. KG	Replacement Saw Blade SR064-105-31	2024-05-10
GUDID 24053613288938 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM800-070-25	2024-05-10
GUDID 24053613288921 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM680-070-15	2024-05-10
GUDID 24053613288914 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM800-060-31	2024-05-10
GUDID 24053613288907 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM800-060-25P	2024-05-10
GUDID 24053613288891 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM550-050-19P	2024-05-10
GUDID 24053613288884 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM550-060-19P	2024-05-10
GUDID 24053613288877 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM990-050-31P	2024-05-10
GUDID 24053613288860 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM650-060-19P	2024-05-10
GUDID 24053613288853 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM125-050-35P	2024-05-10
GUDID 24053613288846 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM550-070-26	2024-05-10
GUDID 24053613288839 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM550-070-18P	2024-05-10
GUDID 24053613288822 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM500-070-12	2024-05-10
GUDID 24053613288815 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM950-070-31	2024-05-10
GUDID 24053613288808 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM550-070-18	2024-05-10
GUDID 24053613288792 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM125-070-35	2024-05-10
GUDID 24053613288785 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM700-070-30	2024-05-10
GUDID 24053613288778 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM680-060-19	2024-05-10
GUDID 24053613288761 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM980-070-25	2024-05-10
GUDID 24053613288754 Gebr. Brasseler GmbH & Co. KG	Replacement Micro Saw Blade SM980-070-19	2024-05-10
GUDID 24053613288709 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM550-060-18P	2024-05-10
GUDID 24053613288693 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM950-060-12P	2024-05-10
GUDID 24053613288679 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM950-060-31P	2024-05-10
GUDID 24053613288662 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM980-060-31P	2024-05-10
GUDID 24053613288655 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM700-060-30P	2024-05-10
GUDID 24053613288648 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM680-060-19P	2024-05-10
GUDID 24053613288631 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM130-060-25P	2024-05-10
GUDID 24053613288624 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM980-060-19P	2024-05-10
GUDID 24053613288600 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO320-100-65	2024-05-10
GUDID 24053613288594 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO325-100-57	2024-05-10
GUDID 24053613288570 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO115-080-73	2024-05-10
GUDID 24053613288556 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO105-100-24	2024-05-10
GUDID 24053613288549 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO276-080-58	2024-05-10
GUDID 24053613288532 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO185-080-60	2024-05-10
GUDID 24053613288525 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO185-100-73	2024-05-10
GUDID 24053613288518 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO228-100-84	2024-05-10
GUDID 24053613288501 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO250-080-73	2024-05-10
GUDID 24053613288495 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO270-120-62	2024-05-10
GUDID 24053613288488 Gebr. Brasseler GmbH & Co. KG	Replacement Saw Blade SR060-105-31	2024-05-10
GUDID 24053613288457 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO480-080-62	2024-05-10
GUDID 14053613289617 Gebr. Brasseler GmbH & Co. KG	Shannon Corta Round Shank SS08652	2024-05-10
GUDID 14053613288719 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM550-060-25P	2024-05-10
GUDID 14053613288689 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM550-060-12P	2024-05-10
GUDID 14053613288610 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM175-060-35P	2024-05-10
GUDID 14053613288580 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO2735-140-67	2024-05-10
GUDID 14053613288566 Gebr. Brasseler GmbH & Co. KG	Replacement Offset Saw Blade SO105-100-29	2024-05-10
GUDID 14053613288467 Gebr. Brasseler GmbH & Co. KG	Replacement Precision Micro Saw Blade SM980-060-25P	2024-05-10
GUDID 24053613291006 Gebr. Brasseler GmbH & Co. KG	Shannon Recta 3 Larga Round Shank DS302075R	2024-05-06
GUDID 14053613289624 Gebr. Brasseler GmbH & Co. KG	Shannon Larga Round Shank SS12652	2024-05-06
GUDID 14053613289600 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Larga Round Shank K20752	2024-05-06
GUDID 14053613289594 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Corta Round Shank K08652	2024-05-06
GUDID 14053613289587 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Round Shank K12652	2024-05-06
GUDID 14053613289570 Gebr. Brasseler GmbH & Co. KG	Wedge 4 Round Shank M41652	2024-05-06
GUDID 14053613289563 Gebr. Brasseler GmbH & Co. KG	Wedge 3 Round Shank M31652	2024-05-06
GUDID 14053613287507 Gebr. Brasseler GmbH & Co. KG	Shannon Larga MBUR2212	2024-04-25
GUDID 14053613287491 Gebr. Brasseler GmbH & Co. KG	Wedge 4 MBUR4313	2024-04-25
GUDID 14053613287484 Gebr. Brasseler GmbH & Co. KG	Wedge 3 MBUR2913	2024-04-25
GUDID 14053613287071 Gebr. Brasseler GmbH & Co. KG	Twist drill PCB43L	2024-04-25
GUDID 24053613288174 Gebr. Brasseler GmbH & Co. KG	Steinmann Pin PC32300	2024-04-24
GUDID 24053613287337 Gebr. Brasseler GmbH & Co. KG	Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC137-090-18	2024-04-16
GUDID 24053613287320 Gebr. Brasseler GmbH & Co. KG	Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC137-090-13	2024-04-16
GUDID 24053613287313 Gebr. Brasseler GmbH & Co. KG	Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC127-100-18	2024-04-16
GUDID 24053613287306 Gebr. Brasseler GmbH & Co. KG	Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC127-090-13	2024-04-16
GUDID 24053613287252 Gebr. Brasseler GmbH & Co. KG	Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC127-100-25	2024-04-16
GUDID 14053613287675 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Larga MBUR2220	2024-04-16
GUDID 14053613287477 Gebr. Brasseler GmbH & Co. KG	Shannon Corta MBUR2008	2024-04-16
GUDID 14053613287460 Gebr. Brasseler GmbH & Co. KG	Shannon Recta 3 Larga MBUR3120	2024-04-16
GUDID 14053613287453 Gebr. Brasseler GmbH & Co. KG	Shannon Recta MBUR2013	2024-04-16
GUDID 24053613267018 Gebr. Brasseler GmbH & Co. KG	Twist drill S2718.098	2024-04-05
GUDID 24053613287917 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Larga P65-106-3030-S	2024-04-03
GUDID 24053613287887 Gebr. Brasseler GmbH & Co. KG	Shannon Recta P65-106-2220-S	2024-04-03
GUDID 24053613287870 Gebr. Brasseler GmbH & Co. KG	Shannon Corta P65-106-2021-S	2024-04-03
GUDID 24053613287863 Gebr. Brasseler GmbH & Co. KG	Shannon Recta P65-106-2020-S	2024-04-03
GUDID 84053613289531 Gebr. Brasseler GmbH & Co. KG	(2) K-Wire Smooth Ø1,4x89mm ED-10986	2024-03-07
GUDID 24053613288440 Gebr. Brasseler GmbH & Co. KG	Shannon Recta X-Larga DS3030100R-S	2024-03-07
GUDID 24053613288433 Gebr. Brasseler GmbH & Co. KG	Brophy DB501570R-S	2024-03-07
GUDID 24053613288426 Gebr. Brasseler GmbH & Co. KG	Wedge 4 DW411365R-S	2024-03-07
GUDID 24053613288419 Gebr. Brasseler GmbH & Co. KG	Wedge 3 DW311065R-S	2024-03-07
GUDID 24053613288396 Gebr. Brasseler GmbH & Co. KG	Shannon Larga DI201265R-S	2024-03-07
GUDID 24053613288389 Gebr. Brasseler GmbH & Co. KG	Shannon Corta DI208065R-S	2024-03-07
GUDID 14053613288405 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Larga DI222075R-S	2024-03-07
GUDID 24053613289379 Gebr. Brasseler GmbH & Co. KG	Saw Blade for Stryker® P65-151-P300-S	2024-02-29
GUDID 14053613287668 Gebr. Brasseler GmbH & Co. KG	Guide Screw Set TKR.IN.1332	2024-02-27
GUDID 14053613287651 Gebr. Brasseler GmbH & Co. KG	Guide Screw Set TKR.IN.1311	2024-02-27
GUDID 14053613287644 Gebr. Brasseler GmbH & Co. KG	Guide Screw Set TKR.BB.1312	2024-02-27
GUDID 84053613287636 Gebr. Brasseler GmbH & Co. KG	Guide Screw Headless Threaded TKR.IN.1332	2024-02-26
GUDID 84053613287629 Gebr. Brasseler GmbH & Co. KG	Guide Screw Headless Threaded TKR.IN.1331	2024-02-26
GUDID 84053613287612 Gebr. Brasseler GmbH & Co. KG	Guide Screw Headless Threaded TKR.IN.1352	2024-02-26
GUDID 84053613287605 Gebr. Brasseler GmbH & Co. KG	Guide Screw Headless Threaded TKR.BB.1500	2024-02-26
GUDID 24053613285739 Gebr. Brasseler GmbH & Co. KG	Steinmann Pin PCGW27	2024-02-26
GUDID 14053613285749 Gebr. Brasseler GmbH & Co. KG	Steinmann Pin PCGW27L	2024-02-26
GUDID 14053613287705 Gebr. Brasseler GmbH & Co. KG	ARVIS Hip Pin Pack 160-00-001	2024-02-15
GUDID 14053613287699 Gebr. Brasseler GmbH & Co. KG	ARVIS Ancillary Pin Pack 150-00-002	2024-02-15
GUDID 14053613287682 Gebr. Brasseler GmbH & Co. KG	ARVIS Knee Pin Pack 150-00-001	2024-02-15
GUDID 24053613287849 Gebr. Brasseler GmbH & Co. KG	Shannon Recta X-Larga Round shank P65-106-3031-S	2024-02-12
GUDID 24053613287832 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Larga Round shank P65-106-2221-S	2024-02-12
GUDID 24053613287825 Gebr. Brasseler GmbH & Co. KG	Shannon Recta Round shank P65-106-2013-S	2024-02-12
GUDID 24053613287818 Gebr. Brasseler GmbH & Co. KG	Wedge 4 Round shank P65-106-4313-S	2024-02-12
GUDID 24053613287801 Gebr. Brasseler GmbH & Co. KG	Wedge 3 Round shank P65-106-2913-S	2024-02-12
PMN K193472 | NKB Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	Pedicle Screw System	2020-02-24
PMN K193472 | KWQ Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	Pedicle Screw System	2020-02-24
HWT Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	ROD TEMPLATE	2019-04-08
GFG Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SURGICAL BUR, GENERAL & PLASTIC SURGERY	2016-02-23
PMN K955697 | DZE Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	Abutment Retrieval Kit	2015-04-09
PMN K131264 | JDW Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SCREW, FIXATION, BONE	2013-12-18
PMN K131264 | JDW Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, THREADED	2013-12-18
PMN K131264 | JDW Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, SMOOTH	2013-12-18
PMN K131264 | HWC Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SCREW, FIXATION, BONE	2013-12-18
PMN K131264 | HWC Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, THREADED	2013-12-18
PMN K131264 | HWC Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, SMOOTH	2013-12-18
PMN K131264 | HTY Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SCREW, FIXATION, BONE	2013-12-18
PMN K131264 | HTY Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, THREADED	2013-12-18
PMN K131264 | HTY Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PIN, FIXATION, SMOOTH	2013-12-18
GFC Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET Driver, Surgical, Pin	2013-12-18
EKN Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET PAPER POINTS	2013-08-26
EKM Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET GUTTAPERCHA	2013-08-26
PMN K131264 GEBR. BRASSELER GMBH & CO. KG	KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS	2013-07-26
PMN K990846 | DZI Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET BONE CUTTING INSTRUMENT AND ACCESSORY	2010-08-04
HXC Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS	2010-08-04
OHW Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET STEEL BURR FOR OPHTHALMOLOGY	2010-01-12
PMN K090548 | EFB Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET OSCILLATING CONTRA-ANGEL	2009-07-03
PMN K071352 | EJL Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET CERADRILL	2009-04-15
NDP Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET MaxilloPrep	2009-04-14
PMN K944714 | EFB Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SONIC HANDPIECE	2009-04-02
PMN K071352 GEBR. BRASSELER GMBH & CO. KG	CERADRILL	2007-06-29
EIY Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS	2007-02-21
EJQ Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET WHEEL POLISHING AGENT	2006-08-23
EIL Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET DEPTH GAUGE	2006-08-23
EHM Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET POLISHING STRIP	2006-08-23
DZA Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET INTRAORAL DENTAL DRILL	2006-08-23
FSM Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET TRAY SURGICAL INSTRUMENT	2006-05-30
EKK Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ROOT CANAL SPREADER, NERVE BROACHES	2006-05-30
EKS Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE	2005-10-31
EKR Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ENDODONTIC ROOT CANAL PLUGGER	2005-10-31
EKQ Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ENDODONTIC ROOT CANAL PREPARE	2005-10-31
EKP Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ENDODONTIC ROOT CANAL REAMER	2005-10-31
GFF Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY	2005-10-19
EQJ Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET BUR EAR, NOSE AND THROAT	2005-10-19
ELR Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ROOT CANAL POST	2005-10-19
EBL Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET RETENTIVE AND SPLINTING PINS	2005-10-19
GFA Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET SURGICAL SAW BLADE GENERAL & PLASTIC SURGERY	2005-09-09
EJL Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET DENTAL BURS	1981-08-24
EHL Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ABRASIVE POINT	1981-08-24
EHJ Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET ABRASIVE DISK	1981-08-24
DZP Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]	KOMET DENTAL DIAMOND INSTRUMENTS	1981-08-24

Related Finance Registrations

NCAGE Code	D9676	GEBR. BRASSELER GMBH & CO KG
CAGE Code	D9676	GEBR. BRASSELER GMBH & CO KG