Recorded Data: Product Approvals

Below are product approval insights of Medtech Companies

Company Month Approval type
Propeller Health July 510(k)
Medrobotics July 510(k)
Oxford Performance Materials July 510(K)
Altona Diagnostics July Emergency Use Authorization
Propeller Health July 510(k)
Abbott July PMA
Meridian Biosciences July 510(k)
Magellan Diagnostics July 510(k)
St Jude Medical July PMA
Integrum AB July Humanitarian Device exemption
NanoVibronix July 510(k)
Thoratec July CE Mark
Cryolife July PMDA approval
Cynosure July 510(k)
Cardiovascular Systems July 510(k)
Kubtec July 510(k)
Theranos July 510(k)
Proteus Digital Health July Expanded 510(k)
Hansen Medical July 510(k)
MX Orthopedics July 510(k)
GlySure July CE mark
SpineGuard June CFDA approval
BioLight June CE mark
Velano Vascular June CE mark
Caldera Medical June 510(k)
Exactech June 510(k)
Medtronic June PMA
Biocartis June CE mark
Advanced Cooling Therapy June De novo
Cochlear June PMA supplement
Siemens June 510(k)
Quidel June 510(k)
Masimo June CE mark
Torax Medical June PMA
Medtronic June PMA
SomnoMed June 510(k)
ALung Technologies June CE mark
Admedus June HSA approval
Wicab June De novo
Agfa Healthcare June 510(k)
Centinel Spine June 510(k)
Analytica June 510(k)
Aesculap June 510(k)
Alcon June CE mark
Ventana Medical Systems June PMA
Masimo June CE mark
TriVascular Technologies June PMA
Breathe Technologies June 510(k)
Cerebral Assessment Systems June De novo
FH Ortho June 510(k)
Merck Serono June CE mark
Merck Serono June CE mark
Sanovas June 510(k)
St Jude Medical June PMA
Asuragen June CE mark
Ariosa Diagnostics June CE mark
Medical Informatics June 510(k)
Elekta June CE mark
Beckman Coulter Diagnostics June CE mark
Beckman Coulter Diagnostics June CE mark
Sebia June CE mark
Linkage Biosciences June CE mark
QuanDx June CE mark
Chembio Diagnostics June CE mark
Merz North America June PMA
Actavis June null
St Jude Medical June CE Mark
Roche June 510(k)
CareStream Health June 510(k)
Cohero Health June 510(k)
Monarch Medical Technologies June 510(k)
Cyberonics June PMA
Mobidiag June CE mark
Biomatlante June CE mark
Rivanna Medical June 510(k)
SurgiQuest May 510(k)
EOS Imaging May 510(k)
Penumbra May 510(k)
Verax Biomedical May 510(k)
VertiFlex May PMA
InvisionHeart May 510(k)
Roche May 510(k)
Seegene May CE mark
Terumo Medical May PMA
BioNTech May CE mark
St Jude Medical May HEalth Canada approval
Mauna Kea May CE mark
Cleveland HeartLab May CE mark
Implanet May 510(k)
Silk Road Medical May PMA
Abbott May CE mark
Arterial Remodelling Technologies May CE mark
BrainScope May 510(k)
Magstim May 510(k)
LabStyle Innovations May Health Canada approval
Ablative Solutions May CE mark
BD Medical May 510(k)
St Jude Medical May CE mark
Calgary Scientific May MDCO certification
Toshiba May 510(k)
Biologic Therapies May 510(k)
Biologic Therapies May 510(k)
Medtronic May PMA
Medtronic May CE mark
Roche May PMA
Nevro May PMA
Surefire Medical May CE mark
Beckman Coulter May 510(k)
LinkSPINE May 510(k)
Medtronic May 510(k)
Biotronik May CE mark
Medtronic May 510(k)
Medtronic May Expanded 510(k)
Invictus Medical May 510(k)
Advanced Medical Solutions May Expanded CE mark
The Medicines Company April null
The Medicines Company April null
St Jude Medical April PMA supplement
Greatbatch Medical April PMA
Abbott April 510(k)
Ellipse Technologies April 510(k)
Stentys April CE mark
Strauss Surgical April Health Canada approval
Avita Medical April CE mark
InspireMD April ANVISA approval
Bruker April CE mark
Avioq April null
Avioq April Expanded CE mark
FH Ortho April 510(k)
Nipro Diagnostics April 510(k)
Siemens April PMA
Coloplast April null
Clear Guide Medical April CE mark
Rayence April 510(k)
Great Basin Scientific April 510(k)
Biomedica Immunoassays April CE mark
Medtronic April CE mark
Natus Medical April 510(k)
Invivoscribe Technologies April CE mark
Invivoscribe Technologies April CE mark
Alcyone Lifesciences April 510(k)
Syneron Medical April 510(k)
MindChild Medical April 510(k)
Hyperbranch Medical Technology April PMA
Cardiovascular Systems April 510(k)
AcuFocus April null
Biotronik April null
Biotronik April null
Cepheid April CE mark
Meditech Spine April 510(k)
CardiacAssist April CE mark
Cepheid April CE mark
Focus Diagnostics April 510(k)
Abbott April 510(k)
CAS Medical Systems April null
Conventus Orthopaedics April 510(k)
Perseon April Expanded 510(k)
Medtronic April CE mark
Hansen Medical April CE mark
Quirem Medical April CE mark
Eyenuk April CE mark
Waters April CFDA approval
Haag-Streit Surgical April 510(k)
Epistem/ Xcelris Labs April Ministry of Health and Family Welfare
Alcon/ Novartis April PMA supplement
Sophia Genetics April CE mark
ivWatch April 510(k)
HeartWare International April Health Canada approval
Perseon April 510(k)
IRIS April 510(k)
Mobidiag April CE mark
HemCon Medical Technologies April CFDA approval
Synaptive Medical April 510(k)
Advanced Breath Diagnostics April null
Ethicon Endo-Surgery April null
Cytori Therapeutics/ Lorem Vascular April CFDA approval
Bruker April 510(k)
Augmenix April 510(k)
On-X Life Technologies April null
Abbott April null
Alere April 510(k)
AirStrip April 510(k)
Boston Scientific April CE mark
NEC Display Solutions of America April 510(k)
Baxter International April CE mark
Lensar April 510(k)
Berry Genomics March CFDA approval
Berry Genomics March CFDA approval
Medtronic March PMA supplement
Novocure March MHLW approval
Medtronic March MHLW approval
Voyant Health March 510(k)
Imris March Health Canada approval
K2M March CE mark
K2M March 510(k)
Vital Art and Science March 510(k)
Stryker March 510(k)
Stryker March 510(k)
Theradiag March CE mark
Cepheid March Emergency use authorization
Wright Medical March 510(k)
Critical Diagnostics March CFDA approval
Voyant Health March 510(k)
Thermo Fisher Scientific March CE mark
NovaBone Products March 510(k)
NovaBone Products March 510(k)
Illumina March Health Canada approval
Illumina March Health Canada approval
Abiomed March PMA
Biotronik March null
Cutera March MFDS approval
Becton Dickinson March CE mark
Vascular Pathways March 510(k)
Semler Scientific March 510(k)
Vascular Pathways March 510(k)
Medtronic March PMA supplement
Silver Bullet Therapeutics March CE mark
CorMatrix Cardiovascular March ANMAT approval
Etiometry March 510(k)
Boston Scientific March CE mark
Boston Scientific March PMA supplement
Quidel March 510(k)
VuCOMP March null
Roche March CE mark
Boston Scientific March PMA
St Jude Medical March Reinstated CE mark
Toshiba America Medical Systems March 510(k)
Lombard Medical March MHLW approval
JustRight Surgical March CE mark
JustRight Surgical March CE mark
JustRight Surgical March CE mark
Philips/Volcano March CE mark
Theradiag March CE mark
Tornier March 510(k)
Somna Therapeutics March 510(k)
TomTec Imaging Systems March 510(k)
ZOLL Medical March PMA
Advanced Bionics March CE mark
Aerocrine March 510(k)
Kaneka March Humanitarian device exemption
Life Spine March 510(k)
Calgary Scientific March PMDA approval
Oraya Therapeutics March Extended CE mark
Roche March CE mark
Seegene March Health Canada approval
Alere March CE mark
Allergan February null
Actavis February null
Meridian Bioscience February CE mark
Boston Scientific February 510(k)
Corgenix Medical February Emergency use authorization
Masimo February MFDS approval
Meridian Bioscience February CE mark
Meridian Bioscience February CE mark
Meridian Bioscience February CE mark
bioMérieux/ BioFire Diagnostics February 510(k)
bioMérieux/ BioFire Diagnostics February CE mark
AqueSys February Health Canada approval
Cyberonics February CE mark
Novacyt February CFDA approval
Providence Medical Technology February CE mark
Providence Medical Technology February CE mark
Providence Medical Technology February CE mark
bioLytical Laboratories February null
Cynosure February 510(k)
Bioness February 510(k)
Pie Medical Imaging February 510(k)
Medtronic February PMA
McGinley Orthopaedic Innovations February 510(k)
Neuronetrix February 510(k)
23andMe February De novo
Medtronic February Expanded 510(k)
Seegene February 510(k)
Dallen Medical February 510(k)
Simplify Medical February CE mark
Mevion Medical Systems February Health Canada approval
Medtronic February CE mark
Alere February CE mark
Cepheid February Expanded 510(k)
NeoMend February PMA supplement
Sonoma Orthopedic Products February 510(k)
Pelvalon February De novo
Vital Connect February PMDA approval
Titan Spine February 510(k)
Medicatech USA February 510(k)
Medicatech USA February 510(k)
Agendia February 510(k)
Silk Road Medical February 510(k)
Velano Vascular February 510(k)
Cohera Medical February PMA
Nanotherapeutics February 510(k)
Sorin February PMDA approval
Chembio Diagnostics February ANVISA approval
Koning February PMA
Distal Access February 510(k)
Nevro February CE mark
Medtronic February PMA
Premaitha Health February CE mark
Lombard Medical February PMA supplement
WL Gore & Associates February Health Canada approval
Amedica February null
SpineGuard February 510(k)
OrthAlign February CE mark
Advanced Bionics February CE mark
Advanced Bionics February CE mark
Precision Spine February 510(k)
Iridex February 510(k)
EyeTechCare February CE mark
MedShape February 510(k)
Amsel Medical February 510(k)
Medtronic February CE mark
Leonard Hair Transplant Associates January 510(k)
Aerocrine January PMDA approval
AngioDynamics January 510(k)
Zeltiq Aesthetics January 510(k)
Luminex January Health Canada approval
Blue Belt Technologies January CE mark
Aesculap Implant Systems January 510(k)
Agilent Technologies January CFDA approval
Medtronic January PMA
Abiomed January HDE
St Jude Medical January null
Medtronic January PMA
Decisio Healthcare January null
InspireMD January CE mark
Bioceptive January 510(k)
EOS Imaging January null
PARI Respiratory Equipment January null
DexCom January De novo
Roche January 510(k)
MED-EL USA January null
Medtronic January Humanitarian device exemption
BioStructures January 510(k)
AliveCor January CE mark
Summit Medical January 510(k)
Medtronic (ev3) January PMA supplement
K2M January 510(k)
ERBA Diagnostics January CE mark
Applied Spectral Imaging January 510(k)
Summit Medical January 510(k)
Dymicron January CE mark
Hospira January 510(k)
NEC Display Solutions of America January 510(k)
ECA Medical Instruments January 510(k)
Eurocor January CE mark
Signostics January 510(k)
Mar Cor Purification January 510(k)
Enteromedics January PMA
Cerapedics January TGA approval
Cerapedics January CE mark
ALung Technologies January TGA approval
Diaxonhit January CE mark
Valorem Surgical January 510(k)
Qiagen January CE mark
Tandem Diabetes Care January 510(k)
Intact Medical January Expanded 510(k)
Second Sight Medical Products January Health Canada approval
EDAP TMS January Health Canada approval
Roche January null
Myriad Genetics January CE mark
Covidien January CE mark
PorOsteon January 510(k)
HGI Industries January 510(k)
Qiagen January 510(k)
Straub Medical January CFDA approval
Cartiva January 510(k)
Shockwave Medical January CE mark
Viztek January 510(k)
Becton Dickinson January 510(k)
Philips January 510(k)
Straub Medical January CFDA approval
Quanta Fluid Solutions January CE mark
Alere January CLIA waiver
Sterotaxis January 510(k)
Sterotaxis January PMDA approval
Medtronic January PMA
Aum Cardiovascular January CE mark
dBMEDx January 510(k)
Biotronik January CE mark

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s