21 results
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21ms
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Sources: EU EUDAMED, US FDA
AMEDITECH IMMUTEST DRUG SCREEN PCP
FDA 510(k)
FDA Unclassified
·Unknown
Graftmaster
FDA UDI
ABBOTT VASCULAR INC.·08717648176456·GRAFTMASTER Coronary Stent Graft System 4.00 mm...
Graftmaster
FDA UDI
ABBOTT VASCULAR INC.·08717648176449·GRAFTMASTER Coronary Stent Graft System 4.00 mm...
Graftmaster
FDA UDI
ABBOTT VASCULAR INC.·08717648176463·GRAFTMASTER Coronary Stent Graft System 4.00 mm...
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033427637·
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033427613·
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033427620·
ACON STREP A RAPID TEST STRIP
FDA 510(k)
FDA Class 1
·Microbiology
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STREP A RAPID TEST STRIP (THROAT SWAB)
FDA Adverse Event
Death
·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024
CONSENSUS PS KNEE SYSTEM
FDA Adverse Event
Malfunction
·CONSENSUS ORTHOPEDICS INC.·Product code JWH·July 30, 2014
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·March 20, 2013
PFCSIG CEM FEM STEM5DG13X130MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011
SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL·Product code LTI·March 12, 2008
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code MAF·July 9, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code MAF·July 6, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MAF·July 9, 2020
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·October 16, 2015
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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019