23 results · 32ms · Sources: EU EUDAMED, US FDA

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ELLEX 2RT

FDA 510(k)
FDA Class 2 ·Ophthalmic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II

Peerless Buccal Tube

FDA UDI
ORMCO CORPORATION·00889989053258·PEERLESS 2NDMOL 6DEG UR/LL NDX OTX018

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383505901·Gutta Percha Points is used to root canal filin...

NA

FDA UDI
aap Implantate AG·04042409088780·APS Lag Screw, self-tapping, TL 22, L 110

EON CHOLESTEROL REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GS 3000

FDA 510(k)
FDA Class 2 ·Physical Medicine

NA

FDA UDI
aap Implantate AG·04042409088797·APS Lag Screw, self-tapping, TL 22, L 110

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019

UNKNOWN NEXGEN KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·May 17, 2013

DPM 6 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY BIOMEDICAL ELECTRONICS CO. LTD·Product code MHX·September 18, 2014

OUTBACK RE-ENTRY CATHETER

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code DQY·June 13, 2011

GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022

GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016

GMK PS TIBIAL INSERT SIZE 3 / 17 MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

FDA Enforcement
Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025