17 results
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27ms
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Sources: EU EUDAMED, US FDA
HISTOCHEMICAL PAS REACTION SET
FDA 510(k)
FDA Class 1
·Hematology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327396034·HANDLE INSERT, HEX, RATCHET, CANNULATED
Ceramill® Zolid
FDA UDI
Amann Girrbach AG·E4947600311·
Washbon
FDA UDI
ORMCO CORPORATION·00889989043280·LOWER LEFT SECOND MOLAR WASHBON BAND SIZE 31
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600311·Mand. 2. Bicuspidband left 31
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190950·CHAMFER CUTTING BLOCK SZ 1
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600310501·Mand. 2. Bicuspidband left 31
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600310101·Mand. 2. Bicuspidband left 31
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600310051·Mand. 2. Bicuspidband left 31
KENEX
FDA UDI
KENEX (ELECTRO-MEDICAL) LIMITED·05055449403016·354/76-0031 Center Mnt Shield 76x61cm(no cut-ou...
DEPUY MODULAR M HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
FDA 510(k)
FDA Class 2
·Physical Medicine
KENEX
FDA UDI
KENEX (ELECTRO-MEDICAL) LIMITED·05055449401593·Centre Mount Shield 76x61+cut-out & 2.5m aluminium
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 18, 2013
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 16, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022