53 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TVC IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756612616·Wrist Splint
SCOTT'S SELECT K-FILES 6/pk 31mm # 08
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811231081·ENDODONTIC K-FILES (6/pack) Length: 31mm, Size:...
APTUS PROXIMAL HUMERUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 21, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 31, 2018
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 21, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
DAILY ACTIVITY ASSIST DEVICE - UTENSIL FOR DRESSING, GROOMING, RECREAT
FDA Adverse Event
Injury
·INVACARE·Product code FNG·June 9, 2011
ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 25, 2020
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·September 5, 2017
Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 11, 2018
EVAC STATION
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·January 16, 2018
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 7, 2018
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013