16 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VENOJECT II BLOOD COLLECTION TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Instruments

FDA UDI
Nuvasive, Inc.·00887517385130·ALGI Curette, Down Facing Large

AcQCross Qx Integrated Transseptal Dilator/Needle

FDA UDI
ACUTUS MEDICAL, INC.·00850027837611·

FlexCath Cross™ Transseptal Solution

FDA UDI
MEDTRONIC, INC.·00763000925161·NDL 900309 FLEXCATH CROSS SL 81CM EIFU

Peerless Buccal Tube

FDA UDI
ORMCO CORPORATION·00889989022643·ASSY ORTHOS A/P SGL -4LFM -10X22 LR

FlexCath Cross Transseptal Solution

FDA UDI
ACUTUS MEDICAL, INC.·00850027837925·FlexCath Cross Transseptal Solution– SL 81cm

PRATT CRYPT HOOK

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896020245·PRATT CRYPT HOOK NARROW END

Ortho Specialties

FDA UDI
Young Innovations, Inc.·00843471189214·Comfort Hook™ First Molar Weldable Convertible ...

ShurFit Interbody Device

FDA UDI
PRECISION SPINE, INC.·00840019930826·TLIF Sizer 9mm x 24mm

Elite®

FDA UDI
Ortho Organizers, Inc.·00190707051068·.022/051 U6R TBT/HK

LAGIS ENDOSCOPIC INSTRUMENTS

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

BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

VALIANT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 2014

SCREW

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 7, 2013

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·November 16, 2010

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