20 results
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27ms
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Sources: EU EUDAMED, US FDA
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192749·Modular Tibia Stemmed Keel Drill 13mm
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209102310·KIT, TACTICAL OPERATOR RESPONSE - BASIC - COY
Naida CI Q90 Acoustic Earhook
FDA UDI
Advanced Bionics AG·07630016854798·Left Size 2
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837011871·
Naida CI Q90 Acoustic Earhook
FDA UDI
Advanced Bionics, LLC·00840094454033·Left Size 2
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837011918·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197022699·Ligature Needle
250mm,...
LED Curing Light (C01-X, C02-X)
FDA 510(k)
FDA Class 2
·Dental
Baide
FDA 510(k)
FDA Class 2
·Orthopedic
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA Pre-Market Approval
FDA Class 2
·CA 125 ANTIBODY RIA
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 4, 2014
ENDURON 10D 58 OR 70ODX28ID
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·November 29, 2012
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FPO·September 27, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022