19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
LOW IIONIC STRENGTH SOLUTION
FDA 510(k)
FDA Class 2
·Hematology
Archon
FDA UDI
Nuvasive, Inc.·00887517203885·Archon Screw, 4.0x13mm Self-Tap Var
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77804131·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
MicroFrance®
FDA UDI
INTEGRA MICROFRANCE·10381780089445·MicroFrance® Jennings mouth gag, 130 mm
Azur CX Detachable
FDA UDI
Microvention, Inc.·00810170018299·Azur
NA
FDA UDI
Zimmer, Inc.·00889024133907·
Azur CX Detachable
FDA UDI
Microvention, Inc.·00810170017483·Azur
SurgyNeedle
FDA UDI
U.S. SURGITECH INC.·00810014630069·
Azur
FDA UDI
Microvention, Inc.·00842429119181·Azur CX Detachable
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77804130051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77804130101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77804131001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
TAPE, LIGHTCAST II WB
FDA 510(k)
FDA Class 1
·Physical Medicine
CUSHIONS, DENTURE ADHESIVE, ALL-DAY
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 7, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 10, 2012
SCORPIO CR WAFFLE FEMUR LFIT W/POSTS
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 26, 2010
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
FDA Recall
Terminated
·Microvention, Inc.·Product code KRD·November 24, 2019
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
FDA Enforcement
Class II
·Terminated·Microvention, Inc.·February 19, 2020