22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIAX 2 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
D-Fine Double Diamond™ Final High Shine Refill #02
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003661·Dental burnisher
D-Fine Double Diamond™ Final High Shine Refill #02
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001892·Dental burnisher
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776151690·3FR 255MM FLEXIBLE MONOPOLAR COAGULATION ELECTR...
ELMED
FDA UDI
ELMED INCORPORATED·00842180179790·Pediatric Flexible Monopolar Electrodes, Needle...
STILLE Various Instruments
FDA UDI
Stille AB·07332339209858·WIRE SAWS for PLASTER CAST REMOVER STILLE 100 p...
STILLE Various Instruments
FDA UDI
Stille AB·07332339209841·WIRE SAWS for PLASTER CAST REMOVER STILLE 100 p...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561397·Parallel Rasp Size 12x12x5 mm
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
FDA 510(k)
FDA Class 2
·Physical Medicine
GOLIFE NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·April 13, 2015
INRATIO2
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·May 15, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 17, 2011
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·October 1, 2014
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·July 12, 2016
Artis Q floor, Model Number 10848280
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
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