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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ATEC Lateral Navigation Instruments

FDA 510(k)
FDA Class 2 ·Neurology

M/DN®

FDA UDI
Zimmer, Inc.·00889024039919·

M/DN®

FDA UDI
Zimmer, Inc.·00889024039926·

GUIDEZILLA GUIDE EXTENSION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

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

G7 PPS LTD ACET SHELL 54F

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·November 13, 2018

ATLAS PLUS HF CRT-D

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

ENDOPATH** DEXTRUS* SEAL CAP

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 12, 2013

NEXTAR SPINE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

BONE SCREW, T8 FULL THREAD, 2.7MM/L20MM

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026