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