21 results · 20ms · Sources: EU EUDAMED, US FDA

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NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader

MODIFICATION TO ACCU-CHEK INFORM METER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890122100·Zirlux Titanium Abutment 4.5 mmH, Non-Engaging,...

Battalion

FDA UDI
ALPHATEC SPINE, INC.·00840967186931·Battalion, LLIF Trial, 10°, 22 mm Wide, 10 mm X...

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033387801·

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0112100·Draw Rod, Universal Inline Fixed Inserter

CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400

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

SYNTRA DIALYZER, MODEL SYNTRA 120, 160

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NUVASIVE

FDA Adverse Event
Injury ·NUVASIVE·Product code NKB·January 10, 2011

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 1, 2011

PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020

PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019

ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

FDA Adverse Event
Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHS·September 3, 2020

PREMICRON GREEN 2/0 (3) 30CM SKR19(M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020

PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 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