16 results · 21ms · Sources: EU EUDAMED, US FDA

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CUF-COVER (TM)

FDA 510(k)
FDA Class 2 ·Cardiovascular

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved

CEKA & PRECI-LINE ATTACHMENTS

FDA UDI
Alphadent NV·14260576942101·REVAX M2 SPEC. SPR. PIN 1.95MM 2 PCS

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES

FDA 510(k)
FDA Class 2 ·Microbiology

PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB

FDA 510(k)
FDA Class 1 ·Ophthalmic

VERCISE GEVIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 2, 2024

45° DRILLING ATTACHMENT AO/ASIF COUPLING FOR PEN DRIVE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code DZI·April 2, 2013

FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1 TRANS.

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 22, 2011

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·August 22, 2014

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KWP·May 13, 2016

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KWP·May 13, 2016

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

FDA Enforcement
Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016