18 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm; (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM; (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM; (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM; (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM; (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM; (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM; (12) REF BH130R, Providence-Hosp FCPS Del STR140MM; (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM; (14) REF BH134R, Kelly Forceps Del STR 140MM; (15) REF BH135R, Kelly Forceps Del CVM 140MM; (16) REF BH139R, Dandy Delicate Forceps CVD140MM; (17) REF BH140R, Baby Crile Forceps Del STR 140MM; (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM; (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM; (20) REF BH144R, Crile Forceps STR 140MM; (21) REF BH145R, Crile Forceps CVD 140MM; (22) REF BH150R, Baby Kocher Forceps STR 140MM; (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM; (24) REF BH154R, Crile Forceps Del STR 1X2 140MM; (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM; (26) REF BH160R, Leriche Delicate Forceps STR 150MM; (27) REF BH161R, Leriche Delicate Forceps CVD 150MM; (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM; (29) REF BH166R, Crile Forceps STR 160MM; (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM; (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM; (32) REF BH176R, Crile Forceps STR 1X2160MM; (33) REF BH177R, Crile Forceps CVD 1X2 160MM; (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160; (35) REF BH197R, Birkett Delicate Forceps CVD185MM; (36) REF BH199R, Nissen Delicate Forceps CVP 185MM; (37) REF BH200R, Adson Delicate Forceps STR185MM; (38) REF BH201R, Adson Delicate Forceps CVD 185MM; (39) REF BH202R, Halsted Delicate Forceps STR 185MM; (40) REF BH203R, Halsted Delicate Forceps CVD 185MM; (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM; (42) REF BH206R, Heiss Delicate Forceps STR 200MM; (43) REF BH207R, Heiss Delicate Forceps CVD 200MM; (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM; (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM; (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM; (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM; (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM; (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM; (50) REF BH224R, Sarot Delicate Forceps 240MM; (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM; (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM; (53) REF BH228R, Bengolea Delicate Forceps STR 245MM; (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM; (55) REF BH230R, Bridge Delicate Forceps STR 275MM; (56) REF BH231R, Bridge Delicate Forceps CVD 275MM; (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM; (58) REF BH316R, Pean Artery Forceps STR.165MM; (59) REF BH332R, Spencer-Wells Forceps STR130MM; (60) REF BH333R, Spencer-Wells Forceps CVD 130MM; continued
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM; (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM; (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM; (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM; (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM; (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM; (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM; (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM; (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM; (14) REF BJ037R, Forceps CVD Delicate 145MM; (15) REF BJ038R, Forceps CVD.Delicate 185MM; (16) REF BJ039R, Forceps CVD.Delicate 235MM; (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM; (18) REF BJ042R, Rumel Suture Forceps CVD 240MM; (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM; (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM; (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM; (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM; (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM; (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM; (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM; (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM; (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM; (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM; (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM; (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM; (31) REF BJ060R, Lahey Forceps Long-Serr 225MM; (32) REF BJ061R, Mixter Forceps Long-Serr220MM; (33) REF BJ062R, Mixter Forceps Long-Serr 250MM; (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM; (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM; (36) REF BJ073R, Mixter Forceps Long-Serr 290MM; (37) REF BJ080R, Overholt Forceps # 0 CVD215MM; (38) REF BJ081R, Overholt Forceps # 1 CVD210MM; (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM; (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM; (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM; (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM; (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM; (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM; (45) REF BJ100R, Gemini Clamp RT-ANG140MM; (46) REF BJ102R, Gemini Clamp RT-ANG 180MM; (47) REF BJ103R, Gemini Clamp RT-ANG 200MM; (48) REF BJ104R, Gemini Clamp RT-ANG 230MM; (49) REF BJ106R, Gemini Clamp RT-ANG 280MM; (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM; (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM; (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM; (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM; (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM; (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM; continued
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 19, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; 17) ECONO STERILE MAYO DISS SCISS CV 9"STRLCS/25,Model Number 96-2261; 18) ECONO STERILE MAYO DISS SCISS CVD 9" STER25,Model Number 96-2261A; 19) ECONO STERILE METZENBAUM SCIS STR7"STRLCS/25,Model Number 96-2263A; 20) ECONO STERILE METZENBAUM SCIS STR9"STER CS25,Model Number 96-2266; 21) ECONO STERILE MAYO DISS SCISS CVD 5.5"CS/25,Model Number 96-2433; 22) ECONO STERILE MAYO DISS SCISS CVD 6.75"CS/25,Model Number 96-2435; 23) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437; 24) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437A; 25) ECONO STERILE IRIS SCISS CVD S/S 3.5" CS/25,Model Number 96-2471; 26) ECONO STERILE TOENAIL SCISS CVD 4.5" STER 25,Model Number 96-2492A; 27) ECONO STERILE IRIS SCIS CVD DEL 4 STER CS/25,Model Number 96-2494A; 28) ECONO STERILE IRIS SCIS STR LG RG 4.5 STER25,Model Number 96-2495A; 29) ECONO STERILE IRIS SCISS STR S/S 3.5" CS/25,Model Number 96-2496; 30) ECONO STERILE IRIS SCIS STR S/S 3.5 STER C50,Model Number 96-2497; 31) ECONO STERILE IRIS SCIS CVD S/S 3.5 STER C50,Model Number 96-2499; 32) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500; 33) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500A; 34) ECONO STERILE LISTER BAND SCISS 5.5 STER C50,Model Number 96-2502; 35) ECONO STERILE LISTER BAND SCIS STER 5 1/2 50,Model Number 96-2502M; 36) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503; 37) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503A; 38) ECONO STERILE IRIS SCIS STR S/S 4.5 STER C50,Model Number 96-2504; 39) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505; 40) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505A; 41) ECONO STERILE IRIS SCIS CVD S/S 4.5 STER C50,Model Number 96-2506; 42) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/50,Model Number 96-2506M; 43) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507; 44) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507A; 45) ECONO STERILE SPENCER ST SCIS DEL 3.5 STER25,Model Number 96-2511A; 46) ECONO STERILE LITT SUT SCIS 5 1/2 STER CS/50,Model Number 96-2512; 47) ECONO STERILE LITT SUT SCISS 5 1/2 STER CS25,Model Number 96-2513; 48) ECONO STERILE OR SCIS STR B/B 5.5" STER CS50,Model Number 96-2514; 49) ECONO STERILE METZ SCISS STR STER 5.5" CS/50,Model Number 96-2516; 50) ECONO STERILE METZ SCISS STR STER 5.5" 25/CS,Model Number 96-2517; 51) ECONO STERILE METZ SCISS STRS 5.5" STER CS25,Model Number 96-2517A; 52) ECONO STERILE WIRE CUT SCIS ANG 4 3/4 STRL25,Model Number 96-2519; 53) ECONO STERILE OR SCISS STR S/B 5.5" STER C50,Model Number 96-2520; 54) ECONO STERILE OR SCIS STR S/B 5.5 STER CS50,Model Number 96-2520A;
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·December 27, 2023
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 19, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 19, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 27, 2023
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·July 12, 2023
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 12, 2024
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.
FDA Enforcement
Class II
·Ongoing·Aesculap Inc·March 19, 2025
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELLY HEMOSTAT, Product Code 67140; i) ST. STR MOSQUITO HEMOSTAT 3 1/2"(MHB700), Product Code 67325; j) STERILE CVD MOSQT HEMOST 3 1/2"(MHB710), Product Code 67330; k) STERILE 8" CRVD KELLY HEMOSTAT (CK1008), Product Code 67655; l) STERILE 8" STR KELLY HEMOSTAT (SK1008), Product Code 67660; m) ST MOSQUITO HEMO CURVED FINE PT (P/S), Product Code I68100; n) ST CURVED KELLY HEMOSTAT-TAMPA GEN, Product Code I68310; o) STERILE STRT KELLY HEMOSTAT (ZM-09417), Product Code P-65240; p) STERILE STRT MOSQUITO HEMOSTAT (MHS102), Product Code TRI66140; q) STERILE CURVED KELLY HEMO (ST153), Product Code TRI66765
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product Code 66280; i) STERILE F/P SATIN NEEDLEHOLDER (FN9050S), Product Code 66355; j) STERILE 9 1/2 SPONGE FORCEP (237), Product Code 66360; k) STERILE SATIN NEEDLEHOLDER (FN6060S), Product Code 66375; l) STERILE CURV CRILE FORCEP (CF81810), Product Code 66395; m) STERILE LUCAE FORCEP (BF212), Product Code 66415; n) STERILE 6" SF MAYO NEEDLEHOLDER P/S, Product Code 66430; o) STERILE SATIN FORCEP W/TEETH (AF058S), Product Code 66440; p) STERILE 6" FACIAL NEEDLEHOLDER (FN7070S), Product Code 66470; q) STERILE BAYONET FORCEP (25695), Product Code 66490; r) STERILE WEBSTER NEEDLEHOLDER (WN8080S), Product Code 66500; s) STERILE O-H NEEDLEHOLDER (OHN7098S), Product Code 66510; t) STERILE FEILCHENFELD FORCEP (FS388), Product Code 66515; u) STERILE JEWELERS FORCEP (EA742), Product Code 66560; v) STERILE SATIN IRIS FORCEP W/TEETH IF250S, Product Code 66570; w) STERILE CURV PEAN FORCEP (81890), Product Code 66595; x) STERILE CURV 9-1/2 SPONGE FORCEP (FS950), Product Code 66605; y) STERILE SF MAYO HEGAR NDLHLDR (ST263), Product Code 66655; z) STERILE 6" DRESSING FORCEP (DF6006), Product Code 66755; aa) STERILE MAGILL FORCEP (MAGF9), Product Code 66790; bb) STERILE 7 1/4" TUBE OCCLUDING FORCEP, Product Code 66830; cc) STERILE BAUMGARTNER NEEDLEHOLDER, Product Code 66860; dd) STERILE SATIN IRIS FORCEP CVD. (IF255S), Product Code 66865; ee) STERILE ADSON FORCEP W/TYING PLATFORM, Product Code 66970; ff) ST. WEBSTER NEEDLEHOLDER/LG FINGER LOOPS, Product Code 66975; gg) STERILE CVD IRIS FORCEP (ITF4), Product Code 67005; hh) STERILE FULL CURVED IRIS FORCEP (IF145), Product Code 67015; ii) STERILE UMBILICAL LIL'TIPS FORCEP IF145U, Product Code 67060; jj) STERILE SATIN NEEDLEHOLDER (FN6060SL), Product Code 67115; kk) STERILE SCHNIDT TONSIL FORCEP, Product Code 67170; ll) STERILE BISHOP HARMON FORCEP, Product Code 67175; mm) STERILE MAYO HEGAR NEEDLEHOLDER 8"(16290, Product Code 67260; nn) STERILE UTERINE FORCEP 10" (82810), Product Code 67310; oo) STERILE 8" STR PEAN FORCEP (PF12202), Product Code 67485; pp) STERILE MICRO ADSON FORCEP (AF50MS), Product Code 67505; qq) STERILE ADSON FORCEP MICRO TIP (498MS), Product Code 67560; rr) STERILE PLASTIC FORCEP (BF44), Product Code 67590; ss) STERILE MIXTER FORCEP 5 1/2 (12225), Product Code 67700; tt) STERILE TISSUE FORCEP 8"(TF8000), Product Code 67720; uu) STERILE UMBILICAL FORCEP 1/4 CURVE(IF225, Product Code 67725; vv) STERILE DEBAKEY ATRAUMA FORCEP 8"(22546), Product Code 67740; ww) ST PAS GRADE NEEDLEHOLDER 8"(MHN8PAS), Product Code 67865; xx) ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Product Code 67870; yy) ST OR GRADE WEBSTER N/HOLDER 5"(OR2200), Product Code 67875; zz) ST.MICRO FORCEP 1/4 CRV SER TIP(MC250), Product Code 67885; aaa) STL IRIS FCP 3 1/2" X-FN ANG TP (IFC35FS, Product Code 67910; bbb) STL IRIS FRCP 3 1/2"X-FN STR TP (IFS35FS, Product Code 67915; ccc) STL ADSON FORCEP SMOOTH TIP (598P), Product Code 67925; ddd) ST.HARTMAN EAR DRESSING FORCEP (AF25714), Product Code 67940; eee) STERILE MAYO HEGAR NEEDLEHOLDER, Product Code 67945; fff) STERILE DRESSING FORCEP SERR (DF6003K), Product Code 66200K; ggg) SPONGE FORCEP STRA 9.5" REPRO STERILE, Product Code 66360K; hhh) STERILE 6" SF MAYO NDL HOLDER REPROCESS, Product Code 66430K; iii) STERILE UTERINE FORCEP 10" REPROCESS, Product Code 67310K; jjj) ST CRILE FORCEP,STR 5 1/2" SERR (SC8042), Product Code I67455; kkk) ST. HALSEY NHLDER 5",PAS QLTY TCI (P/S), Product Code I67975; lll) STR. ALLIGATOR M
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024