19 results
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26ms
·
Sources: EU EUDAMED, US FDA
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
FDA Pre-Market Approval
FDA Class 2
·NEODYMIUM-YAG OP LASER OPL-3
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
FDA Pre-Market Approval
FDA Class 2
·NEODYMIUM-YAG OP LASER OPL-3
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
FDA Pre-Market Approval
FDA Class 2
·NEODYMIUM-YAG OP LASER OPL-3
PIRANHA
FDA UDI
SPINAL ELEMENTS·00840916112417·3-L CERV PLATE-64mm
Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
FDA Pre-Market Approval
FDA Class 3
·BIOFLOW(TM)
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020780·Full Hemisphere Reamer Size 64
Persona®
FDA UDI
Zimmer, Inc.·00889024559639·
Persona®
FDA UDI
Zimmer, Inc.·00889024559721·
Persona®
FDA UDI
Zimmer, Inc.·00889024559547·
Persona®
FDA UDI
Zimmer, Inc.·00889024559455·
XLD AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·CORAB-M
HFV PATIENT CIRCUIT
FDA Adverse Event
Malfunction
·BUNNELL·Product code LSZ·September 14, 2012
HFV PATIENT CIRCUIT
FDA Adverse Event
Malfunction
·BUNNELL·Product code LSZ·September 14, 2012
HFV PATIENT CIRCUIT
FDA Adverse Event
Malfunction
·BUNNELL·Product code LSZ·September 14, 2012
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDJ·May 23, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·September 7, 2010
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024