20 results · 28ms · 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.

LAPEX 2000

FDA 510(k)
FDA Class 2 ·Physical Medicine

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091034009·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0360090·Distractor, Modular Tip

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710450340090·Medial Guide, Closing Wedge Osteotomy, 34mm x 9mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710820340090·Zadik Calcaneal Guide, 34mm x 9°

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710610340090·Tri-Channel Met-Traverse, 34mm x 9mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710620340090·Quad Channel Met-Traverse, 34mm x 9mm

TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE

FDA 510(k)
FDA Class 2 ·Cardiovascular

3M ATTEST 290 AUTO-READER

FDA 510(k)
FDA Class 2 ·General Hospital

TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

TRANSDUCER, S8 3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

TRANSDUCER S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·April 3, 2013

ASR UNI FEMORAL IMPL SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011

PINN LNR CON +4 10D 32IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·April 25, 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

OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

FDA Enforcement
Class II ·Ongoing·Osteomed, LLC·December 15, 2021