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