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

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LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM

FDA 510(k)
FDA Class 2 ·Immunology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V

Map-iT

FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020138·Fixed Curve Decapolar Catheter with Guidewire Tip

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228566·Curette, large, 2.25x3mm serr,ang 35deg, 5 5/8"

BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 19, 2019

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

FDA 510(k)
FDA Class 2 ·Orthopedic

MINICAP TRANSFER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 30, 2014

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013

LIFEPAK 1000 DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·November 12, 2010

4.5MM TI CORTEX SCREW SELF-TAPPING 38MM

FDA Adverse Event
Malfunction ·SYNTHES GRENCHEN·Product code HWC·March 25, 2015

TI DHS®/DCS® COMPRESSION SCREW 36MM

FDA Adverse Event
Injury ·SYNTHES GRENCHEN·Product code JDO·March 23, 2015

HARMONIC SCALPEL HAND PIECE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 26, 2024

Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

FDA Enforcement
Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

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