13 results · 29ms · Sources: EU EUDAMED, US FDA

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AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

FDA 510(k)
FDA Class 2 ·Cardiovascular

NexxZr™ T / D-100-20-NT-B300-SD

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112934·

ORTHO SUMMIT SAMPLE HANDLER

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

NUVASIVE NEUROVISION JJB SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

VELSCOPE VX

FDA 510(k)
FDA Class 2 ·Dental

BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·April 24, 2023

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 29, 2013

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 16, 2011

POWERLINK SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·August 20, 2008

SYRINGE 30ML LL S/C 56

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·December 18, 2023

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023