28 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GAMBRO LUNDIA FIBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MASTERGRAFT® STRIP
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169486485·STRIP 7800336 MASTERGRAFT 36 CM
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750000661·VITROS Immunodiagnostic Products NTx Controls
MASTERGRAFT® Strip
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169719385·STRIP 7800336 MASTERGRAFT STRIP 36CM
MASTERGRAFT® STRIP
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994487339·STRIP 7800336 MASTERGRAFT 36 CM
MGB Alert® Enterovirus Primer Mix ASR - 48 Reactions
FDA UDI
Elitechgroup Mdx LLC·03661540951312·"MGB Alert® Enterovirus Primer Mix contains che...
0800,APS0,08,N,L1,L2,MUSIC NOTE,RDL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152952·0800,APS0,08,N,L1,L2,MUSIC NOTE,RDL
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
FDA 510(k)
FDA Class 2
·Microbiology
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
FDA 510(k)
FDA Class 2
·Immunology
UNKNOWN- UNSPECIFIED BY COMPLAINANT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·April 3, 2014
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 9, 2012
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 16, 2010
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 13, 2018
RESOLUTE INTEGRITY RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·July 13, 2018
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code HSD·September 13, 2019
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
FDA Recall
Terminated
·Etac Supply Center Ab Langgatan 12 Anderstorp Sweden·Product code ILS·June 15, 2015
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
FDA Recall
Terminated
·Etac Supply Center Ab Langgatan 12 Anderstorp Sweden·Product code ILS·July 12, 2015
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011