17 results · 34ms · Sources: EU EUDAMED, US FDA

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GRADIA GUM

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033808·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...

Acid Etchant

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746071003·ADHESIVE ACID ETCHANT GEL SYRINGE TIP 20/PK

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00811801037528·Straight LLIF Distractor, 8 Deg Lordotic, 9mm

TAKE 1

FDA 510(k)
FDA Class 2 ·Dental

SLEEPBITE

FDA 510(k)
FDA Class 2 ·Dental

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 8, 2024

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

NO CODE AVAILABLE

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

UNKNOWN DEPUY SZ 5 12.5MM STAB TIB INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 3, 2013

ASR ACETABULAR CUPS 56

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

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·April 24, 2008

PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

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