16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FL BOND II
FDA 510(k)
FDA Class 2
·Dental
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·00096295115840·Walkers, All TypesPrivate Label Product Descrip...
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613275122·
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613206621·
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
CAVEX STABISIL
FDA 510(k)
FDA Class 2
·Dental
EXPRO ELITE SNARE
FDA Adverse Event
Injury
·VASCULAR SOLUTIONS, INC·Product code MMX·June 19, 2017
LINEAR? ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 10, 2025
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013
BURR-ATTACHM L F/EPD+APD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 9, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 30, 2022
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
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