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

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ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

Cohere

FDA UDI
Nuvasive, Inc.·00887517013125·COHERE TLIF-O Trial, 10x10mm 4°

Cutimed® Sorbion®

FDA UDI
BSN medical GmbH·04042809703085·CUTIMED SORBION BORDER STERILE 10X23CM 10

Mini Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746108457·DB BKT MINI MS UL LAT 018 T+18 A+6 R=0

OsteoMed

FDA UDI
OSTEOMED LLC·00845694055116·Light Cable

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NEEDLELOK HYPODERMIC NEEDLE PROTECTION

FDA 510(k)
FDA Class 2 ·General Hospital

SURGIMEND

FDA Adverse Event
Other ·TEI BIOSCIENCES INC.·Product code FTM·January 15, 2013

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

FDA Recall
Terminated ·Exsurco Medical·Product code GFD·April 17, 2018

SURGIMEND

FDA Adverse Event
Other ·TEI BIOSCIENCES INC.·Product code FTM·December 19, 2012

OT VERIO IQ METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

FDA Adverse Event
Injury ·EDWARDS LIFESCEINCES·Product code KRH·August 6, 2008

Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004

FDA Enforcement
Class II ·Terminated·Exsurco Medical·July 4, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

SMARTXIDE 50 HS

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013