20 results
·
34ms
·
Sources: EU EUDAMED, US FDA
PEDIATRIC ANESTHESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
Helix
FDA UDI
Nuvasive, Inc.·00887517137906·Helix R Screw, 4x11mm Var Self-Drill
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038011111·NUPRO® Prophy Paste, Orange, Coarse, 340g Jar, ...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117477·Jaffe Tying Forceps, Curved
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016302·ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 3...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016319·ROD CONNECTOR, PARALLEL CLOSED 18mm OFFSET, Ø 3...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016289·ROD CONNECTOR, PARALLEL CLOSED 12mm OFFSET, Ø 3...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016272·ROD CONNECTOR, PARALLEL CLOSED 10mm OFFSET, Ø 3...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016296·ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 3...
PANORET, MODEL 1000A
FDA 510(k)
FDA Class 2
·Ophthalmic
LEGION HINGE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·October 17, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
BD¿ IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMG·February 16, 2018
BD PHASEAL¿ INJECTOR LUER LOCK N35
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 21, 2018
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
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