9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LITETOUCH DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Symmetry Surgical®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482052051·Symmetry® Forceps, Penfield Watchmaker, 7 in
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962107935·PENFIELD WATCHMAKER FORCEPS, 0.9MM TIP, 7"
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
FDA 510(k)
FDA Class 2
·Cardiovascular
Q LAB SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MMI·April 16, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 16, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 5, 2011
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015