20 results · 23ms · Sources: EU EUDAMED, US FDA

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LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05

FDA 510(k)
FDA Class 2 ·Cardiovascular

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033159·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...

SlimLine®

FDA UDI
ZIMMER SPINE, INC.·00889024404038·

CORDIS SLALOM PTA BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

HRH-63-8 HEAD ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

BD UNKNOWN PIVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code ONB·July 31, 2024

BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 14, 2024

OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KOG·March 1, 2013

SM304 M-SERIES W/ZOOM

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·February 28, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2008

LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024