19 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OLYMPUS ENDOSCOPIC LIGATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00174041·
MOBILE FLOSS 2 FLOSSING TEETH BUSINESS CARDS TRIAL PACK
FDA UDI
PRACTICON, INC.·00723896025468·Imprinted Business card containing an 11 yard c...
Sonova Brand
FDA UDI
Sonova AG·07613389475203·myPhonak Junior app
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973509·
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC AVE BRIDGE X3 STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·March 7, 2013
BIOMET INTERLOK 79MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·February 25, 2011
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·February 19, 2008
VUELOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
VEULOCK SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
HERO GRAFT
FDA Adverse Event
Death
·CRYOLIFE, INC.·Product code DSY·August 27, 2015
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024