58 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820303200·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840916126155·InCORPorate VBR Implant 40 W x 30 L x 32 H mm P...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175078·Z-Rod, Dia. 5.5mm, Titanium, 320mm
Holder, Needle, Micro, Streamline/catch round-handle heavy 25cm tip 2.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034006924·Holder, Needle, Micro, Streamline/catch
round-...
PTA-OS SIZING BALLOON, MODEL 360
FDA 510(k)
FDA Class 2
·Cardiovascular
SONOS AIRES 600 (SA-600)
FDA 510(k)
FDA Class 2
·Radiology
Holder, Needle, Micro, Streamline round-handle heavy 25cm tip 2.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034225806·Holder, Needle, Micro, Streamline
round-...
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862158093·
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862156693·TRIAL, CR FEMORAL, LOGIC®, RIGHT, SIZE 2
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 2, 2022
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·March 28, 2013
ESSX HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·March 21, 2011
6464602R PCA II PUMP REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·April 16, 2008
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013
LOGIC CR TIB INSERT SLOPE+, SZ 2, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 11, 2022