19 results · 29ms · Sources: EU EUDAMED, US FDA

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Kosmos

FDA 510(k)
FDA Class 2 ·Radiology

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756141284·Resistive Exercise Cord

Ti-Fix OLIF Spacer

FDA UDI
Tyber Medical, LLC·M695P32121000·Ti-Fix OLIF Spacer 32 x 12 x 10 (mm) x 0 °

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702399745·E2/AG/CT-E/NOP5-T-OH/BR

HONOUR™ Spacer System

FDA UDI
NEXXT SPINE, LLC·00889929002896·Cervical PEEK, 6°, 12mm W x 12mm D x 10mm H

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR75212121001·Buccal tube Andrews .018" f. weld. max. 6 left

iBed Wireless

FDA UDI
STRYKER CORPORATION·07613327519938·

HONOUR™ Spacer System

FDA UDI
NEXXT SPINE, LLC·00889929002902·Cervical PEEK, 0°, 12mm W x 12mm D x 10.0mm H

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

POWDERED VINYL EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

OSS POROUS IM STEM 18.5 X 225

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 17, 2017

SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·July 8, 2011

ENDO GIA UNIVERSAL 12MM SINGLE USE INST

FDA Adverse Event
Injury ·NORTH HAVEN - USS·Product code GDW·October 24, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 8, 2013

OSS SEGMENTAL ELLIPTICAL FEMORAL 7 CM RIGHT POROUS COATED

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 6, 2017

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code KQO·October 18, 2018

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·July 10, 2019

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020