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

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CREATION CP-ZI PORCELAIN

FDA 510(k)
FDA Class 2 ·Dental

Vial Adapter

FDA UDI
WEST PHARMA. SERVICES IL, . LTD·07290108240887·Vial Adapter 13mm FLL SIL- VF

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704507249·

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695199·Wide Implant Drill Kit

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695243·Titanium Base Abutment Internal Hex. NP H3mm En...

LifeBand® Load-distributing Band

FDA UDI
Zoll Circulation, Inc.·00849111002219·Single-use chest compression band. (1 per pack...

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

FDA 510(k)
FDA Class 2 ·Ophthalmic

RS-4M+MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

SPECTRA WAVEWRITER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 17, 2025

CARTRIDGE

FDA Adverse Event
Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

CUSA EXCEL 23KHZ CEM NOSECONE

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES (IRELAND) LIMITED·Product code LFL·April 15, 2013

ARCHITECT HAVAB IGM REAGENT

FDA Adverse Event
Malfunction ·ABBOTT·Product code LOL·April 27, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015