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

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SECURE-LOCK

FDA 510(k)
FDA Class 2 ·Orthopedic

Zavation

FDA UDI
Zavation LLC·00842166133068·Ti3Z CIF 14mmx16mmx6mm -9 deg

HUMERIS 135

FDA UDI
FX SOLUTIONS·03701037318560·HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY PE/TA...

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037318041·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...

DeBakey Extra-Fine Multi-Purpose Clamp 60° 20mm 14.5cm straight shanks

FDA UDI
Geister Medizintechnik GmbH·04057034058213·DeBakey Extra-Fine Multi-Purpose Clamp 60° 20...

MINICONE Implant

FDA 510(k)
FDA Class 2 ·Dental

ZIMMER TRABECULAR METAL TOTAL ANKLE

FDA 510(k)
FDA Class 2 ·Orthopedic

COVEREDGE? 32

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2025

TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018

TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018

JOHNSON & JOHNSON

FDA Adverse Event
Malfunction ·Product code LPL·October 31, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·July 11, 2013

TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

LIFE SCOPE PT

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

FDA Enforcement
Class I ·Ongoing·Kirwan Surgical Products, LLC·December 25, 2024

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