Company ยท US
Carefusion 2200 Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2021. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
114recalls (0 in 12 months)
73recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 47 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 22 |
| GCJ | Laparoscope, General & Plastic Surgery | 18 |
| PXI | Thoracentesis Tray | 14 |
| FSH | Tray, Surgical, Needle | 5 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 4 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 |
| OCV | Endoscope Holder | 2 |
| OJU | Skin Prep Tray | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| DXC | Clamp, Vascular | 1 |
| EMF | Knife, Surgical | 1 |
| GCB | Needle, Catheter | 1 |
| GDF | Guide, Needle, Surgical | 1 |
| HDF | Speculum, Vaginal, Metal | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HGD | Applicator, Vaginal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2021 | K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 Carefusion 2200, Inc. | DXC |
| May 4, 2017 | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments Carefusion 2200, Inc. | GEI |
| Jan 18, 2017 | K162432 | Multi-Link X2 ECG Cable and Lead Wire System Carefusion 2200, Inc. | DSA |
| Aug 25, 2016 | K160764 | AirLife Autofill Humidification Chamber Carefusion 2200, Inc. | BTT |
| Mar 21, 2016 | K153554 | Genesis Low Temperature Reusable Rigid Container System Carefusion 2200, Inc. | KCT |
| Feb 1, 2016 | K151036 | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments Carefusion 2200, Inc. | GCJ |
| Jan 8, 2015 | K142529 | Genesis Reusable Rigid Container System Carefusion 2200, Inc. | KCT |
| Aug 27, 2014 | K140850 | GENESIS REUSABLE RIGID CONTAINER SYSTEM Carefusion 2200, Inc. | KCT |
| Apr 21, 2014 | K140761 | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA Carefusion 2200, Inc. | HES |
| Sep 7, 2012 | K113407 | SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS Carefusion 2200, Inc. | GEI |
| Apr 27, 2012 | K112535 | GENESIS REUSABLE RIGID CONTAINER SYSTEM Carefusion 2200, Inc. | KCT |
| May 6, 2011 | K110257 | DIAMOND-FLEX(R) GRASPERS Carefusion 2200, Inc. | GCJ |
| Dec 2, 2010 | K102179 | ENVIEW (TM) Carefusion 2200 | OCV |
| Dec 23, 2009 | K093616 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART Carefusion 2200 | OCV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7271; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED, REF SP90-7220; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Sep 30, 2024 | Carefusion 2200 Inc Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device Open, Classified |
GCJ | K930667 |
| Apr 21, 2023 | Carefusion 2200 Inc (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 Open, Classified |
HDF | None listed |
| Mar 9, 2023 | Carefusion 2200 Inc CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name:
1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF;
2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID;
Open, Classified |
KCT | K142529 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5073 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301 Open, Classified |
GEI | K213386 |
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