12 results · 18ms · Sources: EU EUDAMED, US FDA

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SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040058807·Irrigating Needles Closed End

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20238431·Steel arches Straight-Arch-F. mand. .017"x.025"

ENVIVE MINIFORMS

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

AUTOSET SPIRIT CPAP SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·March 10, 2020

SECUR-FIT MAX 127 HIP STEM #9

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·March 27, 2013

1.0MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWE·March 14, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2008

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018