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

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SURGICAL DRAPES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040014646·Zirlux 16+ 0M1 55x19x15

CAPSTONE CONTROL™ Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169108981·SPACER 4011422 12 DEG 14X22

Capstone Control PTC Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169677548·SPACER 5011422 CONTROL PTC 12 DEG 14X22

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033277317·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033277324·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033277300·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033277331·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033277348·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112220·Tap, 4.75mm Cortical, SNI1

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112220·Tap, 4.75mm Cannulated, Fixed Sleeve

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER

FDA 510(k)
FDA Class 2 ·Neurology

PSN HEMODIALYZER, MODELS PSN 170, PSN 210

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 19, 2025

PLUM A+ - ANIMAL HEA

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015

PROSIMA PELVIC FLOOR REPAIR KIT

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·March 19, 2013

ASR UNI FEMORAL IMPL SIZE 55

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 14, 2014

SERIES A PAT THN 25 3 PEG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 4, 2021

BIOMET CC CRUCIATE TRAY 63MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 21, 2021