25 results · 28ms · Sources: EU EUDAMED, US FDA

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DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925014633·SHEA CUP PISTON LARGE, LEFT 5.0 MM LENGTH FLUOR...

AGXO

FDA UDI
Oticon A/S·05707131269904·H330, DESIGNRITE 10 WL DBL AGXO

HEANEY-THOREK SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076563·HEANEY-THOREK SCISSORS DOUBLE ARTICULATING FULL...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197382908·Kantrowitz Thorax Clamps curved...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197054607·Kantrowitz Thorax Clamps curved...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197054614·Kantrowitz Thorax Clamps curved...

PILLAR PALATAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

XKNIFE 5

FDA 510(k)
FDA Class 2 ·Radiology

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage

FDA Recall
Terminated ·Cure Medical LLC·Product code EZD·November 11, 2014

LINEAR RLM 7.5FR. 40CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP·Product code DSP·May 29, 2013

ADJ PIN COLLET 2.0 - 3.2MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 17, 2011

COGNIS

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage

FDA Enforcement
Class II ·Terminated·Cure Medical LLC·December 10, 2014

BD VIPER¿ LT SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018