30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
ML-CANADA
FDA UDI
MEDLINE INDUSTRIES, INC.·10889942692811·MYELOGRAM TRAY
Sagix
FDA UDI
Preat Corporation·00842092180341·Sagix 2.2 White Female- Reduced
HHM
FDA UDI
Oticon A/S·05707131163271·K130, MINIRITE SGR HHM
ARGESOL YPF STRIP
FDA UDI
ARGEN CORPORATION, THE·D818101362·Gold based noble metal
Preci-Sagix
FDA UDI
Preat Corporation·00842092119549·Sagix 2.2 White Female- Reduced (50-Pack)
Preci-Sagix
FDA UDI
Preat Corporation·00842092108819·Sagix 2.2 White Female- Reduced (6-Pack)
Symmetry Olsen
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785101090·
SImmetry, Pin Guide Insert
FDA UDI
Paradigm Spine GmbH·04260636673740·
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 1, 2022
GOLD CORE 73 LS
FDA 510(k)
FDA Class 2
·Dental
KARL STORZ 3D VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·May 9, 2013
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 19, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 24, 2011
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021