38 results · 23ms · 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.

“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)

FDA 510(k)
FDA Class 2 ·Neurology

MaXcess

FDA UDI
Nuvasive, Inc.·00887517197610·MaXcess 4 Blade, 130mm Left

Syntec-Taichung Non-sterile Bone Plate and Screw Implants

FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864684344·Small T-Plate/Right Angled 3.5 x Head 3Holes x ...

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704515237·

Pomee

FDA UDI
POMEE CORPORATION·G15772411300·Kelly forceps 5 1/2" straight

TOTAL MANDIBULAR SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036062682·

J & J INSTRUMENTS

FDA UDI
J & J INSTRUMENTS INC·00817524026030·KELLY FCP 5.5"" STR

Coral

FDA UDI
Seaspine Orthopedics Corporation·10889981030230·Screw Offset - Closed, 30mm

Sochi

FDA UDI
Altus Spine, LLC·00843210168098·Screw Offset, Closed, 30mm

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·September 25, 2002

CDS HEMATOLOGY CALIBRATOR (CDS CAL)

FDA 510(k)
FDA Class 2 ·Hematology

ENCOMPASS

FDA 510(k)
FDA Class 2 ·Dental

AMS INFLATE/DEFLATE PUMP

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS·Product code FHW·July 26, 1994

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420

FDA 510(k)
FDA Class 2 ·Orthopedic

COVERED STENT

FDA Adverse Event
Injury ·Product code JCT·November 5, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

LD304 MATERNITY BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023