14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
FDA 510(k)
FDA Class 2
·Immunology
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
FDA 510(k)
FDA Class 2
·General Hospital
PNS MAGNETIC STIMULATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 17, 2023
IMP,TSV,4.1MM,SBM,13
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025
CORAIL2 STD SIZE 9
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·April 23, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 31, 2011
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·July 10, 2008
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 21, 2025
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 18, 2024
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 1, 2023
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
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 2120 (21-2120, 21-2125, and 21-2127) 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