37 results · 19ms · Sources: EU EUDAMED, US FDA

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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