16 results · 30ms · 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.

ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS

FDA 510(k)
FDA Class 2 ·Neurology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033011·Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs C...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0130110·Segmental Rod Reducer, Slim, Assembly

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710620330110·Quad Channel Met-Traverse, 33mm x 11mm

OSMONICS SOLUTION DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SELF ETCH BONDING PRIMER

FDA 510(k)
FDA Class 2 ·Dental

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011

COOK TPN CATHETER REPAIR SET

FDA Adverse Event
Malfunction ·COOK INCORPORATED·Product code DQY·April 22, 2008

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 2016

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018