14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARDS DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium
SubRF Std. 64 Tip,Fuse (100 Pulse), 10-Pk, SubRF
FDA UDI
Candela Corporation·00817495024301·SubRF Std. 64 Tip,Fuse (100 Pulse), 10-Pk, SubRF
Rongeur
FDA UDI
KATENA PRODUCTS, INC.·00841668108505·KERRISON RONGEUR SIZE 3
Australis ALIF Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127961·
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
ACCELERATOR RECIPROCATING CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 22, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·April 21, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 8, 2008
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 16, 2019
REFLECTION CONSTRAINED ACETABULAR LINER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025
TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
FDA Recall
Terminated
·Kinetic Concepts, Inc·Product code INX·June 1, 1997
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