20 results · 27ms · Sources: EU EUDAMED, US FDA

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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