13 results
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20ms
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Sources: EU EUDAMED, US FDA
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
FDA 510(k)
FDA Unclassified
·Unknown
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00146241·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001624·artVeneer life lower anteriors, UIL, BL3
SCANLAN® Ultimate® A/V Punch
FDA UDI
SCANLAN INTERNATIONAL INC·00846159000184·SCANLAN® Ultimate® A/V Punch, 4.5 mm
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COUPLING SCREW FOR INSERTION OF DHS BLADES
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code LXH·June 29, 2017
CADD-LEGACY
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·January 21, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 25, 2011
PRECISION LINK
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018