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