15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITA HI-CERAM
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04046114447207·OMOMED SHOULDER SUP SILVER LEFT SIZE 0
Handle
FDA UDI
ADLER ORTHO SPA·08050507130689·HANDLE FOR TURRET
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902060564·CONNECTOR 6902200 ROD 3.2-5.5 TI
Bard® 350ml Urine Meter Foley Tray with Bard EZ-Lok™ Sampling Port
FDA UDI
C. R. Bard, Inc.·00801741029110·Bard® 350ml Urine Meter Foley Tray with Bard EZ...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227859·Wullstein Cup Fcps, very del, cup jaws
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
CAPELLA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
FDA 510(k)
FDA Class 1
·General Hospital
OLYMPUS SURGMASTER ELECTROSURGICAL UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·June 23, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 15, 2010
REGEN/RNGLC+ MULTI 56MM SZ 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013