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