24 results · 22ms · Sources: EU EUDAMED, US FDA

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VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

FDA 510(k)
FDA Class 1 ·Microbiology

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964013209·Endo Carry-on Procedure Kit includes Olympus 5-...

Spot-On Etch

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783000825·Spot-On Etch Bulk 12 gram syringe, 50 tips

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001460·artVeneer life lower anteriors, UIM, D2

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00146011·

PedFuse®

FDA UDI
SPINEFRONTIER, INC.·00190361008514·PedFuse Respond, CNL, 7.0mm x 60mm

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES·Product code LZG·April 16, 2014

URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VERSABOND BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·December 10, 2025

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·May 23, 2026

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·March 15, 2026

ASSURITY MRI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·September 28, 2025

TOTAL ASR ACET IMP SIZE 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013

MICROVASIVE GOLD PROBE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code KNS·February 25, 2011

MENIVAC WITH INTEGRATED CABLE

FDA Adverse Event
Other ·ARTHROCARE CORP.·Product code GEI·February 21, 2008

Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016

Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014

Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Enforcement
Class I ·Terminated·Customed, Inc·December 10, 2014

Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Enforcement
Class II ·Terminated·Customed, Inc·April 20, 2016