Dornier Medtech America Inc

FDA Filings

This page includes the latest FDA filings for Dornier Medtech America Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Dornier Medtech America Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1037955
FEI Number1037955
NameDORNIER MEDTECH AMERICA, INC.
Owner & OperatorDornier MedTech America, Inc.
Contact Address1155 ROBERTS BLVD. Suite 100
Kennesaw GA 30144 US
Official Correspondent
  • John - Hoffer
  • x-770-5146163-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1155 ROBERTS BLVD.
KENNESAW, GA 30144 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Dornier MedTech America, Inc.
Delta III Lithotripter2020-09-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BIPDDSC2020-06-29
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BIPNEEL2020-06-29
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BIPMBLA2020-06-29
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BIP30CLL2020-06-29
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BIP30CLM2020-06-29
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech 105010002020-04-09
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech FTSXCVRLG2020-03-25
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech FTSXCVRSM2020-03-25
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech AX93US31BR2020-03-16
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech AXPEOSB2020-03-09
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech AX93US31B2020-03-09
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MIOT0670L2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MIOT0670R2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MIOT0570L2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MIOT0570R2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0610K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0604K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0510K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0504K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0410K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD0404K2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD06102020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD06042020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD05102020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD05042020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD04102020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech EQD04042020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80VR2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80282020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80262020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80242020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80222020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS80202020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70VR2020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70282020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70262020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70242020-03-04
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP2515SS2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3815AS2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3515AS2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3815SS2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3515SS2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3815A2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3515A2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3815S2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP3515S2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70222020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS70202020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60VR2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60282020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60262020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60242020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60222020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS60202020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49VR2020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49282020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49262020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49242020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49222020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49202020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech CAS49142020-03-03
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BVEN21282020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BVEN112112020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech K23115772020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BCLU21202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BVEN212112020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BVEN11282020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BTET21202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BHAL21202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BEZ221202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BEZ181202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech BEZ151202020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP2515AS2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP2515A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech SLIP2515S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3815AS2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3515AS2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3815SS2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3515SS2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3815A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3515A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3815S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech MERI3515S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP3815A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP3515A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP2515A2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP3815S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP3515S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech APP2515S2020-02-26
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech 480125142020-01-29
Dornier MedTech America Inc
EQUINOX Balloon Dilatation Catheter2019-12-06
Dornier MedTech America Inc.
Dornier Ureteral Stent2019-11-15
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL600RHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL400RHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL270RHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL200RHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL1000SHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL600SHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL400SHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL270SHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL200SHE2019-11-08
DORNIER MEDTECH AMERICA, INC.
Dornier MedTech HOL200SBTHE2019-11-08
Dornier MedTech America Inc
Dornier MINNOW Ureteral Catheter2019-09-18
DORNIER MEDTECH AMERICA, INC.
Medilas H Solvo 35 Laser2018-04-18
Dornier MedTech America, Inc.
Delta III Lithotripter2017-08-08
DORNIER MEDTECH AMERICA, INC.
Medilas H Ball Tip Laser Fiber2016-12-06
DORNIER MEDTECH AMERICA, INC.
Medilas H Slim Laser Fiber2016-12-06
DORNIER MEDTECH AMERICA, INC.
Medilas H Laser Fibers2016-07-28
Dornier MedTech America, Inc.
Medilas H RFID Laser Fibers2015-10-08
DORNIER MEDTECH AMERICA, INC.
GENESIS2015-06-30
DORNIER MEDTECH AMERICA, INC.
GENESIS II2014-11-26
DORNIER MEDTECH AMERICA, INC.
Medilas H RFID Laser Fiber2013-06-07
DORNIER MEDTECH AMERICA, INC.
Medilas H RFID Laser Fibers2013-06-07
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS UROPULSE2013-03-21
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS H30 SOLVO2013-02-01
DORNIER MEDTECH AMERICA, INC.
GENESIS2013-01-18
DORNIER MEDTECH AMERICA, INC.
MEDILAS H LASER FIBERS2012-12-14
DORNIER MEDTECH AMERICA, INC.
GEMINI LITHOTRIPTER2012-09-24
DORNIER MEDTECH AMERICA, INC.
MEDILAS H RFID LASER FIBER2012-08-01
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS D LITEBEAM+ 14702011-12-07
DORNIER MEDTECH AMERICA, INC.
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE2009-02-12
DORNIER MEDTECH AMERICA, INC.
MEDILAS D FAMILY LASERS2008-08-20
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS D 30 LASER, MEDILAS D 10642008-06-27
DORNIER MEDTECH AMERICA, INC.
MEDILAS D FAMILY LASERS2007-05-21
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS H 20 LASER2006-08-01
DORNIER MEDTECH AMERICA, INC.
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM2002-10-25
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS H LASER FIBER CABLES2002-08-21
DORNIER MEDTECH AMERICA, INC.
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS2002-08-19
DORNIER MEDTECH AMERICA, INC.
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE2001-11-19
DORNIER MEDTECH AMERICA, INC.
DORNIER COMPACT ALPHA LITHOTRIPTER2001-04-17
Dornier MedTech America, Inc.
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE1999-09-02
Dornier MedTech America, Inc.
UROWAVE1999-03-12
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA1999-03-12
Dornier MedTech America, Inc.
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE1999-02-26
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILA H1998-11-25
Dornier MedTech America, Inc.
DORNIER COMPACT DELTA LITHOTRIPTER1998-08-21
Dornier MedTech America, Inc.
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM1998-07-10
Dornier MedTech America, Inc.
DORNIER COMPACT DELTA1998-07-07
Dornier MedTech America, Inc.
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM1998-06-23
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)1998-06-19
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)1998-06-05
Dornier MedTech America, Inc.
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM1998-05-29
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER1998-05-14
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)1997-11-03
Dornier MedTech America, Inc.
DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE1997-05-05
Dornier MedTech America, Inc.
MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)1997-04-29
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS FIBER TOME LASER1997-02-19
Dornier MedTech America, Inc.
DORNIER COMPACT S TRANSPORTABLE1996-12-20
Dornier MedTech America, Inc.
DORNIER COMPACT S MOBILE1996-12-20
Dornier MedTech America, Inc.
DORNIER COMPACT S1996-11-05
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE1996-10-08
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER MOBILE1996-04-11
DORNIER MEDTECH AMERICA, INC.
UROTRACT I1995-12-06
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)1995-10-05
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE1995-10-05
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER1995-08-21
Dornier MedTech America, Inc.
MODEL MFL 5000 LITHOTRIPTER1995-04-12
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER COMPACT1994-09-12
Dornier MedTech America, Inc.
DORNIER MFL5000 MOBILE LITHOTRIPTER1994-07-27
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER COMPACT1994-05-04
Dornier MedTech America, Inc.
MODEL MFL 5000 LITHOTRIPTER1993-08-04
Dornier MedTech America, Inc.
MODEL MFL 5000 MOBILE LITHOTRIPTER1993-07-19
Dornier MedTech America, Inc.
MODEL MFL5000 EXPANSION OF INDICATION RANGE1993-03-08
DORNIER MEDTECH AMERICA, INC.
DORNIER FIBERTOME 100 WATT SURGICAL LASER1993-02-18
Dornier MedTech America, Inc.
MODEL HM4 LITHOTRIPTER CHANGE KV SETTING1992-12-08
Dornier MedTech America, Inc.
DORNIER MODELS MFL5000 SHOCK WAVE LITHOTRIPTER1992-12-04
Dornier MedTech America, Inc.
DORNIER MODELS MPL9000 MODIFICATIONS1992-10-29
DORNIER MEDTECH AMERICA, INC.
DORNIER MEDILAS H1992-10-26
Dornier MedTech America, Inc.
MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT1992-08-06
Dornier MedTech America, Inc.
DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER1992-07-29
Dornier MedTech America, Inc.
DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER1992-01-02
Dornier MedTech America, Inc.
DORNIER MODELS HM3 & HM4 LITHOTRIPTER1992-01-02
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER MODEL MFL 50001991-12-20
Dornier MedTech America, Inc.
DORNIER HM4 MOBILE LITHOTRIPTER1991-11-06
DORNIER MEDTECH AMERICA, INC.
DORNIER LASER LITHOTRIPTER IMPACT1991-10-16
Dornier MedTech America, Inc.
DORNIER MPL9000 LITHOTRIPTER1991-10-04
Dornier MedTech America, Inc.
DORNIER MPL 9000 - MOBILE LITHOTRIPTER1991-08-13
Dornier MedTech America, Inc.
DORNIER MPL 9000 - RENAL APPLICATION1991-08-12
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER MODELS HM3 AND HM41991-08-06
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER MODELS HM3 AND HM41991-07-25
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL MFL50001991-07-03
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL MFL50001991-07-03
Dornier MedTech America, Inc.
DORNIER MPL 9000 - RENAL APPLICATION1991-01-18
DORNIER MEDTECH AMERICA, INC.
FLEXISYS1990-12-04
DORNIER MEDTECH AMERICA, INC.
MEDILAS 4060N FIBERTOM(R) SURGICAL LASER1990-11-21
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31990-07-16
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31990-05-03
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31989-10-19
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31989-01-19
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31988-09-30
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31988-02-03
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-12-31
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-12-29
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-12-29
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-09-17
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-06-11
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-06-09
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-05-06
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31987-05-06
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-09-30
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-08-27
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-06-20
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-04-14
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-04-14
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER, MODEL HM31986-02-05
Dornier MedTech America, Inc.
DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)1984-12-19

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