260 results · 29ms · Sources: EU EUDAMED, 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 SàRL 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