15 results · 37ms · Sources: EU EUDAMED, US FDA

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ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE

FDA 510(k)
FDA Class 2 ·Physical Medicine

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033768·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

POWERED MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

MONARCH II IOL DELIVERY SYSTEM

FDA 510(k)
FDA Class 1 ·Ophthalmic

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

FDA Adverse Event
Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

NO CODE AVAILABLE

FDA Adverse Event
Injury ·SYNTHES USA·Product code GXN·March 8, 2016

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·November 20, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 3, 2013

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INT'L., LTD.·Product code KWA·March 17, 2011

DEXTRUS 4135

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·April 25, 2008

PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

FDA Adverse Event
Injury ·SYNTHES USA·Product code GWO·June 21, 2016

Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

FDA Enforcement
Class I ·Terminated·Cook Inc.·March 2, 2016

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