16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE TSH THIRD GENERATION CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300071·Mand. 1. Molar band W-Fit right 07
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482130667·Symmetry® Elevator, Endoplastic Periosteal Spre...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300070501·Mand. 1. Molar band W-Fit right 07
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300070101·Mand. 1. Molar band W-Fit right 07
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300070051·Mand. 1. Molar band W-Fit right 07
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082022789·
SLEEP PROFILER
FDA 510(k)
FDA Class 2
·Neurology
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962152195·ENDOPLASTIC PERIOSTEAL ELEVATOR/SPREADER, 10 1/4"
G7 NEUTRAL ARCOMXL LNR 36MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·February 11, 2025
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 25, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 18, 2010
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 11, 2014
AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024