20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
3D
FDA UDI
Rmo, Inc.·00885797100177·3D MULTIACTION APPLI ASST OF 6
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176152695·Polisher cup RA, Ø6,0 1p
ACUMED
FDA UDI
Acumed LLC·10806378044700·Clavicle Screw Insertion Tool
90 ML PREFILLED PJ
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS RICHMOND·Product code IFP·May 18, 2018
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANCHORAGE SCOPE, MODEL 000003
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536087457·flamenco screw, polyaxial, bronze, Ø 8.0 mm, le...
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536087471·flamenco screw, polyaxial, bronze, Ø 8.0 mm, le...
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536087433·flamenco screw, polyaxial, bronze, Ø 8.0 mm, le...
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536087440·flamenco screw, polyaxial, bronze, Ø 8.0 mm, le...
flamenco™ spinal fixation system
FDA UDI
Ulrich GmbH & Co. KG·04052536087464·flamenco screw, polyaxial, bronze, Ø 8.0 mm, le...
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 23, 2025
OXFORD PARTIAL KNEE SYSTEM - TWIN PEG FEMORAL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 26, 2017
OXFORD PARTIAL KNEE SYSTEM - ANATOMIC MENISCAL BEARING
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 26, 2017
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·October 23, 2012
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·May 8, 2014
UNKNOWN DEPUY SZ2, 15MM FIXED BEARING PS INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023