14 results · 22ms · Sources: EU EUDAMED, US FDA

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Multi-unit Abutments

FDA 510(k)
FDA Class 2 ·Dental

Edge™ Diamond ND012-6M Needle

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002493·Diamond dental bur, reusable

NOVO Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331184451·Gerald Bipolar Forceps - 0.75 mm Tip, straight,...

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331118845·gerald bipolar forceps - 1.00 fine mm tip, stra...

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331118869·gerald bipolar forceps - 1.00 fine mm tip, stra...

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331118852·gerald bipolar forceps - 1.00 fine mm tip, stra...

ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NEXFIN MODEL 2

FDA 510(k)
FDA Class 2 ·Cardiovascular

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·June 26, 2013

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·July 29, 2011

INTERSTIM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 26, 2008

SINGLE USE GUIDWIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code OCY·April 21, 2020

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018