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

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SPIDERX EMBOLIC PROTECTION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Premier Amalgam Carrier

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008753·AMALGAM CARRIER (METAL) REG/LRG

Rumor

FDA UDI
Ortho Organizers, Inc.·00190707004415·Rumor .022 UL1 17T 4A 0O

PREMICRON NONABSORBABLE PET SURGICAL SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

ATTUNE RP TIB BASE SZ 8 CEM

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code NJL·August 15, 2024

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·April 16, 2013

KAIROS DR

FDA Adverse Event
Malfunction ·BIOTRONIK GMBH AND CO.·Product code DXY·June 13, 2008

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 11, 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

HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·August 29, 2018

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018