17 results · 18ms · Sources: EU EUDAMED, US FDA

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STATZYME GLUCOSE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056240·WIRE NI-TEK UPPER .016X.022 PKG/10

NuVasive

FDA UDI
Nuvasive, Inc.·00887517263742·Universal Mallet, Cervical

NA

FDA UDI
KEY SURGICAL, INC.·00849771048152·K-Wire and Steinmann Pin Dispensers, .028-inch...

CONMED

FDA UDI
Conmed Corporation·20653405008849·BIPOLAR ELECTROSURGICAL FORCEPS, 5-1/2" SEMKIN ...

Monosyn Quick Synthetic Absorbable Surgical Suture

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PAP-TRAY II (CATALOG #C600-2)

FDA 510(k)
FDA Class 1 ·Pathology

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 3, 2012

COAGUCHEK S SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·November 13, 2007

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·December 18, 2013

MONOSYN QUICK

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 20, 2022

MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2026

MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023

MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023

MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAM·March 25, 2026

MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

FDA Enforcement
Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 30, 2025