16 results · 21ms · Sources: EU EUDAMED, US FDA

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RHYTIDOMETER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RECEPTAL CANISTER 1000 ML CE

FDA Adverse Event
Malfunction ·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012

RECEPTAL 1.5LITER PE/CE WITH (50/CASE)

FDA Adverse Event
Malfunction ·HOSPIRA LTD.·Product code GCX·August 1, 2011

NON-PVC RECEPT LINER 2000ML/CE(50/CS)

FDA Adverse Event
Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

NON-PVC RECEPT. LINER 2000ML/CE(50/CS)

FDA Adverse Event
Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

NON-PVC RECEPT LINER 2000ML/CE(50/CS)

FDA Adverse Event
Malfunction ·HOSPIRA, LTD.·Product code GCX·June 21, 2011

RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)

FDA Adverse Event
Injury ·HOSPIRA LTD.·Product code GCX·November 18, 2010

RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

FDA Adverse Event
Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

FDA Adverse Event
Malfunction ·HOSPIRA LTD.·Product code GCX·June 24, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·October 23, 2012

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD., HERMON BUILDING·Product code FFT·May 26, 2015

ELECSYS ANTI-TSHR

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·August 21, 2024

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