14 results · 21ms · Sources: EU EUDAMED, US FDA

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SUPRASORB A +AG

FDA 510(k)
FDA Unclassified ·Unknown

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small

Sklar®

FDA UDI
SKLAR CORPORATION·10649111128981·F.O. MAC ENG STYLE SZ2 4.5MM

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 13, 2017

ESU HANDSWITCHING PENCIL

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

ABBOTT PLUM A+INFUSION PUMP, MODEL 11971

FDA 510(k)
FDA Class 2 ·General Hospital

PLUM A+ - ANIMAL HEA

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·October 4, 2024

TENDRIL STS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 14, 2014

5.5MM TAP (CANNULATED)

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 22, 2013

ACUITY

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code LWP·April 28, 2011

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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024