20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
FDA 510(k)
FDA Class 2
·Dental
BELLATEK® ABUTMENT TSV 3.5MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·February 5, 2021
ABUTMENT, PATIENT SPECIFIC, TITANIUM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
BELLATEK ABUTMENT TSV 4.5MM
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·October 30, 2020
LEONE SPA
FDA UDI
LEONE SPA·08033707012016·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 5
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALTUM ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376668765·12mm CORE, NANOTEC BAN 14 x 35 mm 5°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376669359·12mm CORE, NANOTEC KBN 14 x 35 mm 5°
ESON 2 NASAL MASK
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019
IBP ELB INT. ULNA LRG RGT LNG STM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·June 24, 2016
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 3, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 3/4'', Total Volume 0.75 mL, Total Length 10''; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FPA·August 3, 2005
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015