15 results · 21ms · Sources: EU EUDAMED, US FDA

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BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sklar

FDA UDI
SKLAR CORPORATION·10649111107054·ADAPTER F. (06-1201 LEFF)

ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

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

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012

POSEY ERGONOMIC WALKING BET

FDA Adverse Event
Malfunction ·J. T. POSEY CO.·Product code IKX·March 18, 2013

UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDC·June 18, 2008

11.0MM TI HELICAL BLADE 95MM

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code HSB·April 8, 2011

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012

Misys Laboratory System versions 5.2, 5.23 and 5.3

FDA Recall
Terminated ·Misys Healthcare Systems·Product code JQP·January 31, 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