14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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