13 results
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26ms
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Sources: EU EUDAMED, US FDA
PHYSICIAN BARRIER GLOVE, SURGICAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GRASPING FORCEP INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012210·GRASPING FORCEPS SINGLE-ACTION JAWS SHARP FOR T...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746106705·DB BRACKET MINI MS MAND 2ND BICUSPID 022 TQ=-22...
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981141967·Screw Shank Driver A/O
RapidFor™ Pregabalin (PGB) Rapid Test Kit (Urine)
Device
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·On the market
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
FDA 510(k)
FDA Class 2
·Cardiovascular
MALE LATEX COMDOM WITH DOTTED SURFACE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA Adverse Event
Injury
·NORTH AMERICAN STERILIZATION &·Product code MNB·November 17, 2010
UNKNOWN VAPR ELECTRODE
FDA Adverse Event
Injury
·DEPUY MITEK·Product code GEI·January 8, 2013
Pregabalin (PGB) Rapid Test Kit (Urine)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vitrosens Biyoteknoloji Anonim Şirketi·1 device
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 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