19 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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THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902003875·CROSSLINK 8110616 CDH ANT PLT 16MM TI
ASP
FDA UDI
SEDATELEC·03760262490533·The ASP Original, Semi-Permanent Needle, is an ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816895·Richards Adjustable Mastoid Retractor, 16mm, Re...
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642112481·Modular Spacer, 26 mm (W) x 26 mm (L) x 19 mm (...
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106160·Trial, 26 x 16mm, 8 Degree, Tapered, Straight
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973100638·Poly Insert CR, Size 6, 16mm
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
FDA 510(k)
FDA Class 2
·General Hospital
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024