20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257024362·OMOMED SHOULDER SUP SILVER LEFT SIZE I
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032201·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs A...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094035261·ECG, 5-Lead Wire Set, safety DIN .060, snap for...
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
11.0MM TI HELICAL BLADE 105MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HSB·April 3, 2013
S5
FDA Adverse Event
SORIN·Product code DWB·February 24, 2011
DEEP BRAIN STIMULATION LEAD KIT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS·Product code MHY·April 21, 2008
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·April 28, 2022
PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 14, 2025
PREMICRON GREEN 2/0 (3) 30CM SKR19(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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