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 Number3006157980
FEI Number3006157980
NameKOMET USA LLC
Owner & OperatorGEBR. BRASSELER GMBH & CO. KG
Contact Address25 TROPHAGENER WEG
LEMGO DE-NOTA D-32657 DE
Official Correspondent
  • Petra Meier
  • 49-5261-701-311
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3042 Southcross Blvd. Suite 101
ROCK HILL, SC 29730 US



Registration Number8010468
FEI Number3002806577
NameImke Lindenbeck
Owner & OperatorGEBR. BRASSELER GMBH & CO. KG
Contact Address25 TROPHAGENER WEG
LEMGO DE-NOTA D-32657 DE
Official Correspondent
  • Petra Meier
  • 49-5261-701-311
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3042 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
DeviceDate
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR125-120-732024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR125-106-732024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR135-100-722024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC190-127-1002024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC190-119-1002024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC170-127-100F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-119-90F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-100-90F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-089-90F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC220-127-90F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC220-127-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC190-127-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC190-100-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC190-089-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-127-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-089-902024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-100-70F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-127-70F2024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC800-127-602024-11-19
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-137-90F2024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC220-119-90F2024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-119-902024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-100-902024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC100-127-902024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC130-127-702024-11-15
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC800-119-702024-11-15
Gebr. Brasseler GmbH & Co. KG
Steinmann Pin & K-Wire Set 3400-01-0002024-11-15
Gebr. Brasseler GmbH & Co. KG
ConMed® DC089-064-352024-11-08
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-135242024-10-31
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTZ-2P-000-102024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTZ-2P-035-332024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Pin & Guide Screw Set HTD-00-1112024-10-21
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTZ-2P-000-112024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTSN-2P-760322024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTZ-2P-025-252024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTZ-2P-041-002024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTZ-2P-040-482024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTZ-2P-040-332024-10-21
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-441702024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTD-4P-02-3022024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Screw HTD-4P-02-3032024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTD-4P-02-3002024-10-21
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-03-1502024-10-21
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-03-1002024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTS-4P-2038A2024-10-21
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTZ-2P-020-002024-10-10
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-441402024-10-10
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-441102024-10-10
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-135272024-10-10
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTZ-4P-020-002024-10-10
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTS-4P-03-0902024-10-10
Gebr. Brasseler GmbH & Co. KG
Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.13142024-10-02
Gebr. Brasseler GmbH & Co. KG
Tungsten carbide finisher 123-603-012024-09-23
Gebr. Brasseler GmbH & Co. KG
Tungsten carbide finisher 123-603-312024-09-23
Gebr. Brasseler GmbH & Co. KG
Tungsten carbide finisher 123-604-312024-09-23
Gebr. Brasseler GmbH & Co. KG
Tungsten carbide finisher 123-604-012024-09-23
Gebr. Brasseler GmbH & Co. KG
Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.13132024-09-23
Gebr. Brasseler GmbH & Co. KG
Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.13172024-09-06
Gebr. Brasseler GmbH & Co. KG
Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.13162024-09-06
Gebr. Brasseler GmbH & Co. KG
Guide Screw Set - APOLLOKNEE PIN PACK TKR.IN.13152024-09-06
Gebr. Brasseler GmbH & Co. KG
KOMET Steel bur S2727.098.2024-08-23
Gebr. Brasseler GmbH & Co. KG
KOMET Twist drill S2722.098.2024-08-23
Gebr. Brasseler GmbH & Co. KG
KOMET Steel bur S2721.098.2024-08-23
Gebr. Brasseler GmbH & Co. KG
KOMET Twist drill S2719.098.2024-08-23
Gebr. Brasseler GmbH & Co. KG
Saw Blade for Stryker® SC100-127-902024-08-13
Gebr. Brasseler GmbH & Co. KG
KOMET Twist drill S2725.098.2024-08-12
Gebr. Brasseler GmbH & Co. KG
KOMET Dental Carbide Burs H33CRS.104.021 STE2024-08-09
Gebr. Brasseler GmbH & Co. KG
Shannon Recta Larga P65-106-3020-S2024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Corta TM220082024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Corta TM120082024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Recta TM120132024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Recta Larga TM122202024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Larga TM122122024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Recta Larga TM131202024-08-06
Gebr. Brasseler GmbH & Co. KG
Wedge 4 TM243132024-08-06
Gebr. Brasseler GmbH & Co. KG
Wedge 4 TM143132024-08-06
Gebr. Brasseler GmbH & Co. KG
Wedge 3 TM229132024-08-06
Gebr. Brasseler GmbH & Co. KG
Wedge 3 TM129132024-08-06
Gebr. Brasseler GmbH & Co. KG
Shannon Corta SS056522024-07-26
Gebr. Brasseler GmbH & Co. KG
Replacement Saw Blade SR117-120-782024-07-25
Gebr. Brasseler GmbH & Co. KG
Replacement Saw Blade SR117-105-782024-07-25
Gebr. Brasseler GmbH & Co. KG
Replacement Saw Blade SR125-108-682024-07-25
Gebr. Brasseler GmbH & Co. KG
Shannon Recta X-Larga P65-105-3030-S2024-07-25
Gebr. Brasseler GmbH & Co. KG
Shannon Recta Larga P65-105-2220-S2024-07-25
Gebr. Brasseler GmbH & Co. KG
KM Saw Blade 7001-40SB2024-07-22
Gebr. Brasseler GmbH & Co. KG
Reciprocating saw blade SR125-106-682024-07-22
Gebr. Brasseler GmbH & Co. KG
Oscillating Saw Blade SC254-100-70F2024-07-22
Gebr. Brasseler GmbH & Co. KG
Oscillating Saw Blade SP190-137-902024-07-22
Gebr. Brasseler GmbH & Co. KG
KOMET Dental Tungsten Carbide Burs H1SE.314.0232024-07-16
Gebr. Brasseler GmbH & Co. KG
KOMET Dental Tungsten Carbide Burs H1SE.314.0182024-07-16
Gebr. Brasseler GmbH & Co. KG
KOMET Dental Tungsten Carbide Burs H1SE.314.0142024-07-16
Gebr. Brasseler GmbH & Co. KG
Guide Pins & Guide Screws GP002.070.032.2024-07-16
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Bur S2728.098.2024-07-16
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Bur S2723.098.2024-07-16
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS1925.M63.2024-07-09
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS2525P.L63.2024-07-08
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS2513P.M63.2024-07-08
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS2512P.M63.2024-07-08
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS1313.M63.2024-07-08
Gebr. Brasseler GmbH & Co. KG
KOMET Surgical Saw Blade MDS1312.M63.2024-07-08
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
Pedicle Screw System2020-02-24
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
Pedicle Screw System2020-02-24
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
ROD TEMPLATE2019-04-08
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SURGICAL BUR, GENERAL & PLASTIC SURGERY2016-02-23
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
Abutment Retrieval Kit2015-04-09
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SCREW, FIXATION, BONE2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, THREADED2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, SMOOTH2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SCREW, FIXATION, BONE2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, THREADED2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, SMOOTH2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SCREW, FIXATION, BONE2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, THREADED2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PIN, FIXATION, SMOOTH2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET Driver, Surgical, Pin2013-12-18
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET PAPER POINTS2013-08-26
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET GUTTAPERCHA2013-08-26
GEBR. BRASSELER GMBH & CO. KG
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS2013-07-26
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET BONE CUTTING INSTRUMENT AND ACCESSORY2010-08-04
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS2010-08-04
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET STEEL BURR FOR OPHTHALMOLOGY2010-01-12
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET OSCILLATING CONTRA-ANGEL2009-07-03
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET CERADRILL2009-04-15
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET MaxilloPrep2009-04-14
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SONIC HANDPIECE2009-04-02
GEBR. BRASSELER GMBH & CO. KG
CERADRILL2007-06-29
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS2007-02-21
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET WHEEL POLISHING AGENT2006-08-23
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET DEPTH GAUGE2006-08-23
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET POLISHING STRIP2006-08-23
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET INTRAORAL DENTAL DRILL2006-08-23
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET TRAY SURGICAL INSTRUMENT2006-05-30
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ROOT CANAL SPREADER, NERVE BROACHES2006-05-30
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE2005-10-31
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ENDODONTIC ROOT CANAL PLUGGER2005-10-31
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ENDODONTIC ROOT CANAL PREPARE2005-10-31
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ENDODONTIC ROOT CANAL REAMER2005-10-31
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY2005-10-19
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET BUR EAR, NOSE AND THROAT2005-10-19
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ROOT CANAL POST2005-10-19
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET RETENTIVE AND SPLINTING PINS2005-10-19
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET SURGICAL SAW BLADE GENERAL & PLASTIC SURGERY2005-09-09
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET DENTAL BURS1981-08-24
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ABRASIVE POINT1981-08-24
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET ABRASIVE DISK1981-08-24
Imke Lindenbeck [GEBR. BRASSELER GMBH & CO. KG]
KOMET DENTAL DIAMOND INSTRUMENTS1981-08-24

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