17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PTFE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365113543·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530187·Ferreira Style Breast Retractor
180x30...
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2022
F10
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G-FORCE PEEK SUTURE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Enforcement
Class II
·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 16, 2018
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 4, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 17, 2014
*
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC·Product code JXG·July 22, 2011
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 27, 2015
STA UNICALIBRATOR (ref. 00675)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018
STA SYSTEM CONROL N + P (ref. 00678)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014