260 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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L-SER KO LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
New Image
FDA UDI
HOLLISTER INCORPORATED·00610075073115·2-Piece Ostomy Skin Barrier, CeraPlus
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158211582·FORCEPS STANDARD TISSUE 1X2 TEETH 6.25"
MEGA SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809155857123·Rod, Ø6.0 x 160mm
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109206·HA PEEK EVOS Straight, ,16mmx8mmx 22mm , FLAT 5...
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 6, 2016
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECICONTROL CLINCHEM MULTI 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 7, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
UNKNOWN SCREWS
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNH·December 6, 2019
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Recall
Open, Classified
·VANTIVE US HEALTHCARE LLC·Product code KDI·January 6, 2026
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
FDA Recall
Terminated
·Roche Diabetes Care, Inc.·Product code NDC·September 14, 2016
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·November 23, 2016
Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code HZJ·February 19, 2015