18 results · 25ms · Sources: EU EUDAMED, US FDA

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CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left

AXIOM BIOLASER LLLT SERIES-3

FDA 510(k)
FDA Class 2 ·Physical Medicine

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033015·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm C...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330160·Coronal Bender, Right

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319718032·Hayden Dermal Curette 6-1/4" (15.6cm), oval spo...

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811050·Keyes Dermal Biopsy Punch, Stainless Steel, 5mm

Omnicurve

FDA UDI
STRYKER CORPORATION·07613327638226·10G 15MM EXTRA LEVEL

CARDIS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD

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

LEAD MODEL 304

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·February 4, 2015

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 3, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 25, 2014

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code NQP·April 22, 2008

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021