17 results
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40ms
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Sources: EU EUDAMED, US FDA
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
FDA 510(k)
FDA Class 2
·General Hospital
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609508·BERCHTOLD 2" DELUXE
INTROCAN SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2015
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 26, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL·Product code LTI·July 21, 2008
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026
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
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