59 results
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20ms
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Sources: EU EUDAMED, US FDA
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code MAX·November 3, 2025
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H;
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code MAX·November 3, 2025
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
FDA Recall
Open, Classified
·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·September 22, 2023
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GET·February 14, 2023
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code MOQ·September 23, 2024
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GEY·February 15, 2023
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W
FDA Recall
Open, Classified
·ARROW INTERNATIONAL Inc.·Product code DQX·February 12, 2024
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.
FDA Recall
Open, Classified
·Stryker Neurovascular·Product code DQX·April 18, 2024
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·July 19, 2022
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Various products which were contract sterilized.
FDA Recall
Open, Classified
·Anewmed Corporation·Product code DQX·May 23, 2019
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code DQX·April 21, 2026
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
FDA Recall
Open, Classified
·Arrow International Inc·Product code DQX·December 12, 2019
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·July 19, 2022
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
FDA Recall
Open, Classified
·Cook Incorporated·Product code DQX·August 16, 2022