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

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Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Dornier MedTech

FDA UDI
Dornier MedTech GmbH·04049958002229·Medilas D LiteBeam+ Diode Laser, 1470 nm, SMA

OsteoMed

FDA UDI
OSTEOMED LLC·00842528110904·T15 Long Self Retaining Screw Driver, QR

LEONE SPA

FDA UDI
LEONE SPA·08033707061076·BRACKETS 22 HIGH WING BIC

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 31, 2024

PURE PECTUS

FDA UDI
KLS-Martin L.P.·00888118142290·BASE, CONNECTOR BARS

CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)

FDA 510(k)
FDA Class 2 ·General Hospital

PTS PANELS MULTI-CHEMISTRY CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CAP TIP SYR LL/LS STER LF PP BLUE SINGLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code KYX·April 14, 2021

BD PHASEAL OPTIMA PROTECTOR

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·March 22, 2023

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

FDA Recall
Open, Classified ·Rayner Intraocular Lenses Limited The Ridley Innovation Centre 10 Dominion Way Worthing United Kingdom·Product code MSS·March 17, 2020

FOXCROSS PTA CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LIT·August 11, 2011

HUDSON CONCHA NEPTUEN

FDA Adverse Event
Malfunction ·TELEFLEX·Product code BTT·September 15, 2014

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 2, 2013

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 7, 2023

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.

FDA Enforcement
Class II ·Ongoing·Rayner Intraocular Lenses Limited·April 29, 2020

VITROS XT Chemistry Products TBIL-ALKP Slides

FDA Enforcement
Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·September 27, 2023

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

FDA Enforcement
Class II ·Ongoing·Stanbio Laboratory, LP·December 13, 2023

VITROS XT Chemistry Products ALKP Slides

FDA Enforcement
Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·September 27, 2023

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM

FDA Enforcement
Class II ·Terminated·Zimmer, Inc.·September 3, 2014