12 results · 17ms · Sources: EU EUDAMED, US FDA

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SHARIA-LH RIA KIT FOR QUANTITATION HORMO

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526799363·MANUMED ACTIVE WRIST RIGHT SILVER M

Oph.Hook

FDA UDI
KATENA PRODUCTS, INC.·00841668120125·Stamler Corneal Transplant Stabilizer

SleepmatePiezo Film Sensor & Band, Adult, Double Loop

FDA UDI
Ambu A/S·05707480041336·Piezo Film Sensor & Band Adult

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132130·Trial, TLIF, 27L OB CRV 7Deg, 13mm

HYPERION VISIQUANT ANA TEST KIT

FDA 510(k)
FDA Class 2 ·Immunology

LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·May 15, 2014

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 31, 2012

U-BLADE INSERTER

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·August 18, 2010

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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