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