25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3MP COLOR LCD MONITOR, RADIFORCE RX340
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750001484·66 V2 ASSY SMALL 22ID W/HG
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304430808·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304591561·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868343841·
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 27, 2021
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CENTURION PRESSURE INJECTABLE EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 27, 2021
TELAMON FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012
TELAMON® FUSION DEVICE
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
IMPAX CV OUTBOUND (RESULTS MGMT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013
IMPLANTED POWERPICC
FDA Adverse Event
Injury
·C. R. BARD, INC. (BASD)·Product code LJS·June 1, 2011
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KWT·June 5, 2017
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 10, 2018
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016