19 results · 21ms · Sources: EU EUDAMED, US FDA

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MULA (K2-A1)

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

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981215798·No-Profile Interbody, 3-Hole Faceplate 14mm

Holder, Needle, TC, acc. Crile-Wood 26cm

FDA UDI
Geister Medizintechnik GmbH·04057034065624·Holder, Needle, TC, acc. Crile-Wood 26cm ...

TriplePlay

FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021213·FM5 - Grael

HEALICOLL

FDA 510(k)
FDA Unclassified ·Unknown

WARTIE WART REMOVER

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

ONE TOUCH PROFILE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·October 2, 2002

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 1, 2024

ABL800 FLEX ANALYZER

FDA Adverse Event
Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·March 25, 2024

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·September 9, 2011

4MM DIAMOND BALL, 15CM

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·July 17, 2013

NAVLOCK

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·February 3, 2025

SKINTACT

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code MKJ·October 17, 2024

BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

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

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

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

BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

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

BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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