16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
FDA 510(k)
FDA Class 2
·Cardiovascular
C-Taper Head
FDA UDI
Howmedica Osteonics Corp.·07613327016246·Low Friction Ion Treatment
REPROCESSED ATHROSCOPICS BURS
FDA 510(k)
FDA Class 2
·Orthopedic
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
C-TAPER COCR LFIT HEAD 26MM/+5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·September 16, 2010
UHR BIPOLAR 26X53MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWL·September 16, 2010
PSL HA SCREWLESS ACET SHELL
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·April 29, 2011
CURLIN IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL GROUP·Product code FRN·March 18, 2013
UNK ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 18, 2008
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·April 8, 2011
UHR BIPOLAR 26X50MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWL·January 17, 2017
UHR BIPOLAR 26X46MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·October 16, 2017
Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
FDA Recall
Terminated
·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018