26 results · 27ms · Sources: EU EUDAMED, US FDA

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FETALGARD LITE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Harvard Cement normal setting, Single powder, Shade 3

FDA UDI
Harvard Dental International GmbH·EHAR70025031·Zinc phosphate cement

RMO

FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

AirLife™

FDA UDI
AIRLIFE·10889483571262·Misty Finity™ Direct Connect Large Volume Conti...

AirLife

FDA UDI
Carefusion Corporation·10885403039256·Airlife™ Misty Finity™ Direct Conne...

AirLife™

FDA UDI
VYAIRE MEDICAL, INC.·10190752156593·Misty Finity™ Direct Connect Large Volume Conti...

Angiographic Guide Wire

FDA UDI
MEDTRONIC, INC.·00643169856622·WIRE ANG 002503 25PK .035 145 STR SPG

Metal Custom Rx

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746103919·BRACKET MEDIUM TWIN LEFT CENTRAL 018 TQ=+22 A=+...

STAR

FDA UDI
Stryker GmbH·00886385019062·Lateral IM Alignment Assembly - Spring Lock

SunMed

FDA UDI
SUNMED, LLC·10889483005217·WENGER ADULT CHEST PIECE

HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING

FDA 510(k)
FDA Class 2 ·Radiology

MEDART 520 COOLING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

WVSM Wireless Vital Signs Monitor

FDA UDI
ATHENA GTX, INC.·B3945700025030·BP Extension Hose-3 ft

WVSM Wireless Vital Signs Monitor

FDA UDI
ATHENA GTX, INC.·B3945000025030·Carry case/Charger for 10 WVSMs - Orange

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

PORTEX GENERAL ANESTHESIA CIRCUITS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08" X 77" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

X3 TRIATHLON CS INSERT #6 11MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·March 13, 2013

PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DXE·January 28, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code NBW·February 25, 2008