22 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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Clear Guide SCENERGY
FDA 510(k)
FDA Class 2
·Radiology
Sonic
FDA UDI
Sbo Hearing A/S·05714464034635·Sonic SoundLink Connect 3.4.0 iOS
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103456·NEW ORLEANS LENS LOOP
NA
FDA UDI
STRYKER CORPORATION·04546540756602·UNIVERSAL WEDGE 9MM X 30MM (1.5MM BORE)
NA
FDA UDI
STRYKER CORPORATION·34546540756504·1.0MM X 14IN NITINOL GUIDE WIRE
Precision IE 4K
FDA UDI
STRYKER CORPORATION·07613327416336·
NA
FDA UDI
STRYKER CORPORATION·04546540756633·UNIVERSAL WEDGE 10MM X 30MM (1.5MM BORE)
NA
FDA UDI
STRYKER CORPORATION·04546540756619·UNIVERSAL WEDGE 10MM X 20MM (1.5MM BORE)
NA
FDA UDI
STRYKER CORPORATION·34546540756412·1.5MM X 14IN NITINOL GUIDE WIRE
Stryker
FDA UDI
Provision·B504OM2340300270·
NA
FDA UDI
STRYKER CORPORATION·04546540756541·UNIVERSAL WEDGE 7MM X 30MM (1.5MM BORE)
NA
FDA UDI
STRYKER CORPORATION·04546540756626·UNIVERSAL WEDGE 10MM X 25MM (1.5MM BORE)
NA
FDA UDI
STRYKER CORPORATION·04546540756572·UNIVERSAL WEDGE 8MM X 30MM (1.5MM BORE)
Universal DR 1748
FDA 510(k)
FDA Class 2
·Radiology
APOGEE ELITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 28, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 18, 2013
ACTITOUCH, ACT-ADAPTIVE COMPRESSION THERAPY
FDA Adverse Event
Injury
·TACTILE SYSTEMS TECHNOLOGY, INC·Product code JOW·November 18, 2015
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026