21 results
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20ms
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Sources: EU EUDAMED, US FDA
SmartHDM-510 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446896081·SPECIAL, ALTIVATE ANATOMIC ANTE/RETRO-VERSION G...
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002062·CODMAN SLIM-LINE Aneurysm Clip Graft 3mm Diamet...
METAPHYSARY BROACH ESOP RIGHT SIZE 10
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017650·
HHM
FDA UDI
Oticon A/S·05707131351913·G300 SC, BTE PP 13 2.4G 105 C046 TAR HHM
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063358·Ti ILIAC BONE SCREW ASSY, 8.5mm X 65mm X 30°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063341·TI ILIAC BONE SCREW ASSY, 8.5MM X 65MM X 15°
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 13, 2012
CEMENT RESTRICTOR, SMALL AND LARGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOOK COLLAGEN SPACERS, MODEL 1514B
FDA 510(k)
FDA Class 2
·Radiology
GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 11, 2023
GMK-SPHERIKA 02.12.E0413FR TIBIAL INSERT FIXED SPHERE FLEX SIZ4/13 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2023
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·October 14, 2008
ON-Q PAINBUSTER: SILVERSOAKER 5IN: 400ML, 5ML/HR
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·June 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 5, 2011
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025