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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

FDA 510(k)
FDA Class 2 ·Radiology

MICRO-TOUCH

FDA UDI
Ansell Healthcare Product·20884792040543·MICRO-TOUCH Nitrile EP S405 313025 Size XL, Nit...

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091034054·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20340541·BioFinisher wires Euro-Smile-F. max. .017"x.025"

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410340540·Anterior Closing Osteotomy Guide, 34mm x 54mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420340540·Anterio Lateral Closing Wedge Osteotomy Guide, ...

XYLOS XCELL ANTIMICROBIAL DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

FDA 510(k)
FDA Class 2 ·Cardiovascular

466FXXXX

FDA Adverse Event
Injury ·CORDIS CASHEL·Product code DTK·November 19, 2018

2.0MM IMF SCREW SELF-DRILLING 12MM

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code DZL·April 3, 2013

CUST AGILITY FLANGE TALAR SZ3

FDA Adverse Event
Injury ·DEPUY ORHTOPAEDICS, INC.·Product code HSN·March 24, 2011

LIGASURE IMPACT

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 24, 2008

PERCEPT

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 4, 2020

CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.

FDA Recall
Terminated ·Civco Medical Instruments Inc·Product code ITX·January 16, 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