19 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tranberg CLS Laser Applicator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2730 2WAY NRBV
FDA UDI
HANS RUDOLPH, INC.·00817136026732·2730 LESS MPORT 22MM OD EXH
Puget Sound Energy - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)
VOCOM SILICONE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
FDA 510(k)
FDA Class 2
·Orthopedic
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 18, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·August 7, 2019
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 3, 2025
UNKNOWN DEPUY HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·October 16, 2008
ACUVUE 2 BRAND CONTACT LENSES
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·June 28, 2013
IAB: 8 FR - 30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·August 3, 2011
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 20, 2023
SURGICEL ABSORBABLE HEMOSTAT
FDA Adverse Event
Injury
·ETHICON INC.·Product code LMF·July 9, 2018
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2018
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2018
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021