12 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Class IV New Era medical laser device
FDA Enforcement
Class II
·Ongoing·Inova Lasers LLC·November 25, 2020
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 11408424 & 11408425; MAGNETOM Free.Star 11408426 & 11408427; MAGNETOM Mica 11292557; MAGNETOM Sempra 10840815 & 10840816; MAGNETOM Spectra 10655588 & 10837643; (2) Over Ear Headphones SMN: 11060845 used with the following MAGNETOM MRI systems: MAGENTOM Aera 10432914 MAGENTOM Altea 13344915 & 11410371 MAGNETOM Avanto 10849579 MAGNETOM Avanto Fit 11516216 MAGNETOM AvantoFit 10849578 MAGNETOM Cima.X 11647156 MAGNETOM Lumina 11344916 & 11516153 MAGNETOM Prisma 10849582 MAGNETOM PrismaFit 10849583 MAGNETOM Skyra 10432915 & 10849580 MAGNETOM Skrya Fit 11516217 MAGNETOM Sola 11291455 & 11410231 MAGNETOM Sola Fit 11410482 MAGNETOM Terra 10882764 MAGNETOM Terra.X 11371477 MAGNETOM Vida 11060815 & 11516152 MAGNETOM VidaFit 11410481
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·October 11, 2023
MINISCAV (tm) Vacuum Pump
FDA Enforcement
Class II
·Ongoing·R A Medical Services·September 27, 2023
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 Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
FloPatch FP120, REF: FP120-FOT01-005
FDA Enforcement
Class III
·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026