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