16 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MAGNETOM ESSENZA

FDA 510(k)
FDA Class 2 ·Radiology

Gibson Healthcare

FDA UDI
BENCO DENTAL SUPPLY CO.·D74440719251·BENCO C6 4-0 PL GUT 27"/70CM

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO

FDA 510(k)
FDA Class 2 ·General Hospital

SUNPEX TECHNOLOGIES MODEL SE 01

FDA 510(k)
FDA Class 2 ·Physical Medicine

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
KENSTONE METAL·Product code IKX·April 22, 2013

GORE EXCLUDER AAA ENDOPROSTHESIS

FDA Adverse Event
Death ·W. L. GORE & ASSOCIATES·Product code MIH·April 25, 2011

CAPSURE Z NOVUS

FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code LXH·April 25, 2016

REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

FDA Enforcement
Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·February 25, 2026

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 MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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