21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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