17 results · 30ms · 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.

RM BOND, MODEL J032

FDA 510(k)
FDA Class 2 ·Dental

PELVIC MUSCLE THERAPY

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LERMAN & SON CRANIAL ORTHOSIS HELMET

FDA 510(k)
FDA Class 2 ·Neurology

UNK CONSTRAINED LINER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2018

COCR MODULAR HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 27, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 25, 2022

TAPERLOC POR RED/DIST 13.5X147

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018

32MM MOD HEAD COCR -6MM NECK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018

ADVANTAGE FIT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code FTL·April 17, 2013

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·March 31, 2011

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DTB·July 10, 2008

TAPERLOC POR RED/DIST 13.5X147

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018

32MM MOD HEAD COCR -6MM NECK

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018

XP-XP Tibial Tray - Interlok 65 mm Item # 195752

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015