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® CR125-108-712025-01-21
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-127-902025-01-21
Gebr. Brasseler GmbH & Co. KG
Replacement Precision Micro Saw Blade for Stryker®, NSK® SM130-060-39P2025-01-16
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR117-120-782025-01-16
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR064-114-602025-01-16
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO100-080-352024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO250-090-732024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM550-060-12P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM800-070-252024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM500-070-122024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM550-070-182024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM800-060-312024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM800-060-25P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM550-060-25P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM950-060-37P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM550-050-19P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM550-060-19P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM130-060-39P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM125-050-35P2024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO325-100-572024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO2735-140-672024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO105-100-292024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM125-070-352024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CM680-070-152024-12-26
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO270-120-622024-12-26
Gebr. Brasseler GmbH & Co. KG
Premium Micro Sagitall Saw Blade for ConMed®/Linvatec® Hall® CM130-060-502024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO120-100-732024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM550-070-18P2024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Micro Saw Blade for ConMed®/Linvatec® Hall® CM950-070-312024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Micro Saw Blade for ConMed®/Linvatec® Hall® CM680-060-192024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Micro Saw Blade for ConMed®/Linvatec® Hall® CM980-070-252024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Micro Saw Blade for ConMed®/Linvatec® Hall® CM980-070-192024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM550-060-18P2024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM980-060-25P2024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM650-060-19P2024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO115-080-732024-12-23
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM550-070-262024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Micro Saw Blade for ConMed®/Linvatec® Hall® CM700-070-302024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM950-060-12P2024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM980-060-31P2024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM990-050-31P2024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM700-060-30P2024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO320-100-652024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO228-100-842024-12-16
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO480-080-622024-12-16
Gebr. Brasseler GmbH & Co. KG
Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC119-085-212024-12-16
Gebr. Brasseler GmbH & Co. KG
Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC127-064-352024-12-11
Gebr. Brasseler GmbH & Co. KG
Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC089-090-112024-12-11
Gebr. Brasseler GmbH & Co. KG
Guide Pin 2021-12092024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM980-060-19P2024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM175-060-35P2024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO105-100-242024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO276-080-582024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Offset Saw Blade for ConMed®/Linvatec® Hall® CO250-080-732024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC220-100-902024-12-10
Gebr. Brasseler GmbH & Co. KG
Competitive Precision Micro Saw Blade for ConMed®/Linvatec® Hall® CM680-060-19P2024-12-10
Gebr. Brasseler GmbH & Co. KG
Guide Pin 2024-06162024-12-06
Gebr. Brasseler GmbH & Co. KG
Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall® CC254-127-90F2024-12-06
Gebr. Brasseler GmbH & Co. KG
Competitive Reciprocating Saw Blade for ConMed®/Linvatec® Hall® CR117-105-782024-12-06
Gebr. Brasseler GmbH & Co. KG
Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC089-090-182024-12-06
Gebr. Brasseler GmbH & Co. KG
Performance Cut Oscillating Saw Blade for ConMed®/Linvatec® Hall® DC089-075-252024-12-06
Gebr. Brasseler GmbH & Co. KG
Shannon Recta X-Larga MBUR30302024-11-27
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTD-4P-00-7772024-11-25
Gebr. Brasseler GmbH & Co. KG
Guide Pin Set HTSN-149682024-11-25
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-440802024-11-25
Gebr. Brasseler GmbH & Co. KG
Navigation Pin HTS-2P-04-1002024-11-25
Gebr. Brasseler GmbH & Co. KG
Guide Pin HTS-4P-4-003A2024-11-25
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
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
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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