12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarboClear Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207565·Contrast Line 72"(183cm) Female/Rotating Adapte...
EarQ
FDA UDI
Oticon A/S·05707131341334·G20, BTE 13 PP 2.4G 105 C063 EARQ
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLITAIRE 2 REVASCULARIZATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 27, 2013
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 7, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2011
FREESTYLE LIBRE 14 DAY
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023
FREE STYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018