14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXTENDSURE HBFASC CONTROL
FDA 510(k)
FDA Class 2
·Hematology
MiniKut
FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745468·MiniKut Rotary NiTi Endodontic Files .30/.05, 3...
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530311·
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399005243·SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 120mm
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845167·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...
Shannon Recta X-Larga
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613293393·
FJ2000 System
FDA UDI
Paragon 28, Inc.·00889795133113·Shannon-style Recta Bone Burr, 3.0 x 30 x 100, ...
MOST OPTIONS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
FDA 510(k)
FDA Class 2
·Ophthalmic
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
FDA Adverse Event
Malfunction
·MANNKIND CORPORATION - V-GO·Product code LZG·August 17, 2023
LIGACLIP* ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 11, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·May 27, 2008
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