24 results · 24ms · Sources: EU EUDAMED, US FDA

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UNMIAX LAPAROSCOPIC INSTRUMENT

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

Zethon

FDA UDI
ZETHON LIMITED·05060528013505·C-C09 - SMALL CRANIOTOME ATTACHMENT

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828114653·GEN4 INTERACTIVE

Ti-one 101

FDA UDI
HUNG CHUN BIO-S CO., LTD.·04719871590010·Dental Implant Ø3.5, 8 mm Length The Ti-one 101...

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052096·3.5mm x 8mm Standard Screw

Sochi

FDA UDI
Altus Spine, LLC·00843210166209·Standard Screw, 3.5mm x 8mm

HRH-127-ALLEGRA HEAD ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

NC-STAT

FDA 510(k)
FDA Class 2 ·Neurology

Gibralt

FDA UDI
Choice Spine, LP·10885862303028·

Gibralt®

FDA UDI
INNO Holdings, Inc.·M711050021035080·POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X ...

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 6, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·May 9, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

FDA Adverse Event
Injury ·MEDTRONIC EUROPE SARL·Product code LWS·October 6, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021