37 results
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19ms
·
Sources: EU EUDAMED, US FDA
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
FDA Pre-Market Approval
FDA Class 3
·HYPERION LTK SYSTEM
Laser, Ophthalmic
FDA Pre-Market Approval
FDA Class 2
·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
Laser, Ophthalmic
FDA Pre-Market Approval
FDA Class 2
·HYPERION LTK SYSTEM
Laser, Ophthalmic
FDA Pre-Market Approval
FDA Class 2
·HYPERION LTK SYSTEM
EARGO
FDA UDI
Eargo, Inc.·00850010429045·EARGO NEO, Replacement Hearing Device, Right
D-SIGN IV (R&D PROJECT DW265#37)
FDA 510(k)
FDA Class 2
·Dental
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·COOK MBC PTCA BALLOON DILATATION CATHETER
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overnight Therapeutic Lenses for Myopia Management
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z
Lens, Contact, Orthokeratology, Overnight
FDA Pre-Market Approval
FDA Class 3
·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear
SIMILAR DEVICE S7001, PMA # P990071
FDA Adverse Event
Malfunction
·STOCKERT GMBH·Product code LPB·November 13, 2014
SIMILAR DEVICE S7001, PMA # P990071
FDA Adverse Event
Malfunction
·STOCKERT GMBH·Product code LPB·March 10, 2016