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