21 results · 28ms · 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.

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776409326·Smith Sagittal Split Separator Curved Left 9mm

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036008048·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0104020·Caddie, Large, 30mm

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0104020·Caddie, Large, 30mm

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links

ASEPTIC TRANSFER KIT HOUSING

FDA Adverse Event
Injury ·ZIMMER SURGICAL SA·Product code MOQ·December 3, 2018

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

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

ESU HANDSWITCHING PENCIL

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

ASEPTIC TRANSFER KIT HOUSING

FDA Adverse Event
Injury ·ZIMMER SURGICAL SA·Product code MOQ·December 3, 2018

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 19, 2013

SYNCHROMED

FDA Adverse Event
Death ·MEDTRONIC NEUROMODULATION·Product code LKK·March 1, 2011

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·November 14, 2023

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·February 24, 2011

UNKNOWN OXFORD BEARING

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·March 15, 2018

UNKNOWN OXFORD FEMORAL COMPONENT

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HRY·March 15, 2018

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·February 24, 2011

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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