193 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

FDA Recall
Terminated ·Zimmer Trabecular Metal Technology, Inc.·Product code LPH·April 15, 2016

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 Recall
Open, Classified ·Exactech, Inc.·Product code KWZ·August 11, 2022

14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

FDA Recall
Terminated ·Spinal Solutions, LLC·Product code MNI·February 20, 2013

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HSB·December 20, 2017

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 Recall
Open, Classified ·Exactech, Inc.·Product code LPH·August 11, 2022

Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code HET·February 10, 2017

CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

FDA Recall
Terminated ·DRG International Inc·Product code JSO·November 9, 2009

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

EZ-DOP, diagnostic ultrasound imaging system

FDA Recall
Terminated ·DWL Systems, Inc.·Product code IYN·January 5, 2004

CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

FDA Recall
Terminated ·DRG International Inc·Product code JSO·November 9, 2009

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

FDA Recall
Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

FDA Recall
Terminated ·DRG International, Inc.·Product code JKD·December 21, 2021

Total Thyroxine (T4) ELISA; REF EIA-1781

FDA Recall
Open, Classified ·DRG International, Inc.·Product code KLI·October 18, 2021

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CDZ·July 5, 2024

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/

FDA Recall
Open, Classified ·Exactech, Inc.·Product code PHX·August 15, 2025

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

FDA Recall
Open, Classified ·Exactech, Inc.·Product code PHX·August 15, 2025

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09 e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10

FDA Recall
Open, Classified ·Exactech, Inc.·Product code LPH·August 11, 2022

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component.

FDA Recall
Open, Classified ·Exactech, Inc.·Product code LZO·June 29, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

FDA Recall
Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021