12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EsoCheck CCD Cell Collection Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Padded Arm Sling
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357832620·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515028340·Balfour Center Blade, 3 3/8"x2 1/2"
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176793·Standard UHMWPE Insert - shouldered 5 mm
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176809·Standard UHMWPE Insert - shouldered 5 mm
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 6, 2019
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 28, 2011
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023