18 results · 23ms · Sources: EU EUDAMED, US FDA

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SYNTHES 6.5MM MIDFOOT FUSION BOLT

FDA 510(k)
FDA Class 2 ·Orthopedic

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 17, 2016

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014609355·ALLEN, STERIS-AMSCO 2" SOFTCARE

Anti-TCRg/d-PE

FDA UDI
Miltenyi Biotec B.V. & Co. KG·04049934133886·11F2 recognizes the human gamma/delta T cell re...

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

PARADIGM QUICK-SET INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

PCCS GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018

GYNNIE OB-GYN STRETCHER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 26, 2013

INTERSTIM II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 14, 2011

ENDOPATH XCEL BLUNT TIP TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 21, 2008

LEGION PS OXIN FEM SZ5 LT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

GII OVAL RESURFACING PAT 32MM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

FDA Enforcement
Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.

FDA Recall
Terminated ·Maquet Cardiovascular·Product code FZT·June 4, 2010

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