11 results · 29ms · Sources: EU EUDAMED, US FDA

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VANGUARD REPROCESSED ULTRASONIC SCALPEL

FDA 510(k)
FDA Unclassified ·Unknown

MEIJER

FDA UDI
MEIJER, INC.·00708820010000·REGULAR MAXIPAD WINGLESS UNSCENTED 48 CT

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V

INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

FDA 510(k)
FDA Class 1 ·General Hospital

SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE

FDA 510(k)
FDA Class 2 ·General Hospital

ENERGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013

DIAGNOST 56/66/76

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code IXR·February 24, 2011

CONTAK RENEWAL 4

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

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