23 results
·
23ms
·
Sources: EU EUDAMED, US FDA
PILOT TUBE REPAIR KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267888·
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462571·
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021409·7450 V2 LG W/HG & 2730 NRB
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007036·GLOBAL ANCHOR PEG GLENOID PREMIERON X-LINKED PE...
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007029·GLOBAL ANCHOR PEG GLENOID SIZE 56mm CEMENTED
BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 18, 2019
ACQPLAN 5.0
FDA 510(k)
FDA Class 2
·Radiology
PRAEZIS PLUS
FDA 510(k)
FDA Class 2
·Neurology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 25, 2023
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 15, 2013
ARCHITECT TOTAL T3
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code CDP·September 24, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 1, 2011
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021