22 results · 20ms · Sources: EU EUDAMED, US FDA

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EBA2 FEMORAL NAILING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COE-FLEX®

FDA UDI
Gc America Inc.·10386040004831·COE-FLEX® Standard Package Regular Body, Fast S...

COE-FLEX®

FDA UDI
Gc America Inc.·D6581310051·COE-FLEX® Standard Package Regular Body, Fast S...

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564035707·L3 GOWN, PLR XX-LARGE W/TWL

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800283·Gown, Surgical L3, XXL

Pro-Link Ti

FDA UDI
Life Spine, Inc.·00190837080860·

Pro-Fit

FDA UDI
PULMODYNE INC·00841470111250·

MIRABAY

FDA UDI
Mirabay Orthodontics Corp.·05061075029247·OPTIMAL SYMMETRY ARCHWIRE TRANS THERM PL W/STOP...

Trivicta

FDA UDI
Ortho Development Corporation·00822409123704·Collarless EXT Size 5

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180517918·ALIF, MODULAR DISTRACTOR, IMPACTION TIP, 5mm, S...

ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT

FDA 510(k)
FDA Class 2 ·Dental

LUMEND FRONTRUNNER GW CTO CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197398572·Micro Curette backwa...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962162743·MICROCECT CURETTE, BACKWARD ANGLE, #5

6IN AML LRG STATURE 12.0 MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code LPH·October 1, 2014

CONSTELLATION

FDA Adverse Event
Malfunction ·ALCON RESEARCH, LTD.·Product code HQC·April 12, 2013

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 96-2752.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

FDA Enforcement
Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018