14 results · 20ms · Sources: EU EUDAMED, US FDA

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ORTHOPACS

FDA 510(k)
FDA Class 2 ·Radiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033825·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

FILM PROCESSOR, MODEL LIFE RAY PRO 2500

FDA 510(k)
FDA Class 2 ·Radiology

CANDELA SMOOTHBEAM LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RADIESSE DERMAL FILLER

FDA Adverse Event
Injury ·MERZ AESTHETICS·Product code LMH·July 30, 2012

BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 15, 2018

ADVANTAGE SYSTEM

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

UNKNOWN DEPUY ASR HIP

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

PLUS VKS

FDA Adverse Event
Injury ·PLUS ORTHOPEDICS AG·Product code HSH·April 25, 2008

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 22, 2018

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

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