12 results · 20ms · 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.

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

FDA 510(k)
FDA Class 2 ·Dental

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496032465·PERSONALITY 70 SHEER, SIZE 2XXL, CAMEL, GRADUAT...

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032465·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm B...

nSpire Health

FDA UDI
NSPIRE HEALTH, INC.·10852417003696·KoKo Standard White Filter Kit with Nose Clip a...

SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876

FDA 510(k)
FDA Class 2 ·Anesthesiology

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·March 29, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 25, 2011

PATIENT SPECIFIC FOSSA EMINENCE LEFT PROSTHESIS

FDA Adverse Event
Other ·TMJ IMPLANTS, INC.·Product code LZD·April 17, 2008

LIFEPAK CR(R) PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

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

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016