18 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mizzy Consistency
FDA UDI
Keystone Industries·H66860813001·VPS Heavy Body, Reg Set
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894127667·
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370922·GETTINGE / SHAMPANE 1400 1500 1900 SOFTCARE 4"
LEONE SPA
FDA UDI
LEONE SPA·08033707001157·TRAPEZOIDAL SCREWS S/STEEL 14mm
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702367461·Elvarex 3/Knee High/Slant-Open Toe-Elephantiasi...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0183000·Assembly, Handle, Guidewire Grip
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
FDA 510(k)
FDA Class 2
·General Hospital
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 26, 2013
KINETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 21, 2011
PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·July 22, 2008
OSS 7CM DIAHPYSEAL SEGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 16, 2018
ACCESS SHEATH CH10-12 45
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FED·November 8, 2016
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024