15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517276537·CoRoent Large MP, 10x9x28mm 12°
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
FDA 510(k)
FDA Class 2
·Radiology
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL, INC.·Product code LMH·August 17, 2009
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 2, 2025
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 2, 2025
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 2, 2025
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·March 12, 2013
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·March 9, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·March 12, 2008
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·January 26, 2018
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·January 26, 2018
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