27 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,
FDA Recall
Open, Classified
·Wondfo USA Co Ltd·Product code GTY·April 22, 2024
Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile; (6) Presource PBDS Cat. PN40CD806, Kit, Pedi C D, RWJ, Sterile; (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile; (8) Presource PBDS Cat. PN73APVD7, Kit, Neuro Spine Module, Sterile; (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile; (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile; (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile; (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile; (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile; (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile; (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile; (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile; (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile; (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile; (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile; (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile; (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile; (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile; (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile; (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile; (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile; (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile; (27) Presource Complex Spine Pack, Cat. SNE12NS388, Sterile; (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile; (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile; (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile; (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile; (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile; (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile; (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile; (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile; (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile; (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile; (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile; (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile; (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile; (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile; (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile; (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile; (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile; (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile; (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code OJG·August 16, 2023
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KDD·November 17, 2022
CombiDiagnost R90; Model Number: 709031;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025
Radiography 7300 C; Model Number: 712037;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025
ProxiDiagnost N90; Model Number: 706110;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·October 1, 2025
Precision CRF; Model Number: 706400;
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025
ProxiDiagnost N90. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·May 19, 2021
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Recall
Open, Classified
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·July 22, 2020
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Recall
Open, Classified
·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
FDA Recall
Open, Classified
·Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand·Product code ETD·November 24, 2024