19 results · 26ms · Sources: EU EUDAMED, US FDA

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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