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

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MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036028688·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450204979·

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345024113·Paddle Shaver, 16mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0103160·Shaver, Closed, 16mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197510943·Tebbet Breast Retractor 90x16m...

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·October 30, 2014

COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

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

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI

FDA 510(k)
FDA Class 1 ·Microbiology

AEQ REV II GLENOID BASEPLATE DIA 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 2, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

D.4,5MM COMPRESSION SCREW L.32MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

D.4,5MM COMPRESSION SCREW L.23MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

AEQ REV GLENOID BASEPLATE 29MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026