26 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LumiCare Caries Diagnostic Rinse

FDA 510(k)
FDA Class 2 ·Dental

ReLine

FDA UDI
Nuvasive, Inc.·00195377047564·RELINE-O Trial, 5mm H Ang Left L-pop

DOYEN SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083806·DOYEN SCISSORS STRAIGHT SERRATED BLADES POWER C...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694007214·M4 Micro Plate Organizer, Series II

NA

FDA UDI
Biedermann Motech GmbH & Co. KG·04250869611756·MOSS VRS distraction forceps

IRMA C02 MODEL 200101; IRMA AX 200601

FDA 510(k)
FDA Class 2 ·Anesthesiology

MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL

FDA 510(k)
FDA Class 2 ·Radiology

Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

FDA Enforcement
Class II ·Terminated·Bard Peripheral Vascular Inc·March 11, 2020

BD ULTRA-FINE¿ INSULIN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND CO.·Product code FMI·April 5, 2018

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 4, 2015

MENTOR SMOOTH ROUND HIGH PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·February 9, 2021

PFC*SIGMA C/R NPOR FEM RT SZ 2

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·January 15, 2021

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·June 12, 2020

1.5T LINX, 17 BEADS

FDA Adverse Event
Injury ·TORAX MEDICAL, INC.·Product code LEI·January 15, 2021

UNKNOWN HIP ACETABULAR CUP

FDA Adverse Event
Injury ·FINSBURY ORTHOPAEDICS LIMITED·Product code KWA·November 26, 2019

Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02

FDA Recall
Terminated ·Abbott Laboratories Diagnostic Div·Product code JIX·December 23, 2005

Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.

FDA Enforcement
Class II ·Terminated·Bard Peripheral Vascular Inc·March 11, 2020