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

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SUTURTEK FASTCLOSE SUTURING DEVICE

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

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001649·Knee Immobilizer

Asnis

FDA UDI
Stryker GmbH·07613154631360·CANNULATED SCREW

BIO-ABSORBABLE CORKSCREW MODEL AR-1920B

FDA 510(k)
FDA Class 2 ·Orthopedic

UMBICUT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ZEPHIR® ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014

BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FPA·June 11, 2025

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013

EZ-28 DELIVERY SYSTEM

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code MSS·March 27, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011

S.M.A.R.T. NITINOL STENT SYSTEM

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code FGE·April 16, 2008

BIO-CORKSCREW SUTURE ANCHOR

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011

Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

FDA Enforcement
Class II ·Terminated·Ondamed Inc·May 16, 2018

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

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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