26 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Redicare

FDA UDI
REDICARE LLC·B70901030071·40 Fabric Knuckle Bandages Latex Free Heavy Wei...

OptiChamber Diamond

FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000510·DIAMOND WITH LG MASK-PREFERRED PLUS

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193108131·HA PEEK EVOS Straight, ,7mmx9mmx 22mm , FLAT 0...

Altus Spine Cervical Interbody Fusion System

FDA UDI
Altus Spine, LLC·00843210131139·Rasp, No Tab

Stefan Bone Holding Forceps

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896121256·Stefan Bone Holding Forceps With Extra Long Rat...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694044820·2.0mm, L Plates 18mm Rigid, Left & Right, with ...

ROD, FIXATION, INTRAMEDULLARY

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·August 9, 2016

BELLEGLASS HP ENAMEL 2

FDA 510(k)
FDA Class 2 ·Dental

GALAXY

FDA 510(k)
FDA Class 2 ·Dental

PROGAV®

FDA Adverse Event
Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·COCHLEAR LTD.·Product code MCM·May 9, 2013

ENDURANT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·September 19, 2014

M2A MAGNUM PF CUP 62MM X 56MM ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 25, 2011

Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code KNW·December 23, 2019

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·November 13, 2014

Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 12, 2020

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

ROD, FIXATION, INTRAMEDULLARY

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·July 25, 2016