32 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OIS SYMPHONY IMAGE MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118012·LOCATOR R-Tx Attachment System, CSR-DAT Interna...
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075022910·KLEOS 2 PSL METAL MBT 022 UL2 PK5
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193108896·HA PEEK EVOS Straight, ,6mmx11mmx 26mm , FLAT ...
DRAINAGE CATHETER OR FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS Premium, Invenia ABUS Prime
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS (Automated Breast Ultrasound System) 2.0
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS 2.0 Automated Breast Ultrasound System
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS - Automated Breast Ultrasound System
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS- AUTOMATED BREAST ULTRASOUND SYSTEM
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·INVENIA ABUS
Automated Breast Ultrasound
FDA Pre-Market Approval
FDA Class 3
·Invenia ABUS Autoated Breast Ultrasound System
BMT 360 TIBIA AUGMENT 71X15MM LL/RM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 13, 2013
SELOX ST 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·September 23, 2014