22 results · 20ms · Sources: EU EUDAMED, US FDA

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MEDIPALM-20

FDA 510(k)
FDA Class 2 ·Neurology

IMPACT-20

FDA UDI
Denplus Inc·D8451031202·IMPACT-20, LPL, 2.3 kg

Q-RAD System

FDA UDI
CARESTREAM HEALTH, INC.·60889971031204·Q-RAD SYSTEM/QG-8000-3-R10-T920V

Life Instruments

FDA UDI
Life Instrument Corporation·M930703120200·Optical Holder

CEKA & PRECI-LINE ATTACHMENTS

FDA UDI
Alphadent NV·14260576942118·REVAX M2 SPEC. SPR. PIN 2.02 MM 2 PCS

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm

MODIFICATION TO BRAIDED GUIDING INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI BIPOLAR SHEATH

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017

TRULIANT TIB IMP PSC INSERT SZ 3, 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·April 17, 2024

MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017

UNKNOWN DEPUY BONE CEMENT

FDA Adverse Event
Injury ·9610921 DEPUY CMW·Product code LOD·April 2, 2013

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·March 22, 2011

HI-TORQUE WHISPER MS GUIDE WIRE

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·April 17, 2008

MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017

MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017

NEOPUFF INFANT RESUSCITATOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·January 26, 2012

MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017

VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016