14 results · 23ms · 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.

ARGYLE COMPACT CHEST DRAINAGE SYS.

FDA 510(k)
FDA Class 2 ·General Hospital

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)

Infrared Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

STERILE SPONGE BOWLS

FDA 510(k)
FDA Class 1 ·General Hospital

PLUM A+ DRIVER NEW 8

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 18, 2012

NEXGEN STEMMED TIBIAL BROACH IMPACTOR

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code LXH·February 21, 2014

LDR SPINE ROI-A INTERBODY FUSION DEVICE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code MAX·August 6, 2010

BIOMET VANGUARD PATELLA COMPONENTS

FDA Adverse Event
Injury ·.·Product code JWH·July 13, 2017

BIOMET VANGUARD COMPLETE KNEE SYSTEM TIBIAL BEARING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 12, 2017

BIOMET REGENEREX TIBIAL COMPONENTS

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBH·July 13, 2017

BIOMET MCK MAXIMUM CONGRUENT KNEE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 12, 2017

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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