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