19 results · 22ms · Sources: EU EUDAMED, US FDA

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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