Codman & Shurtleff, Inc.
Codman & Shurtleff, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2020, with 59 FDA device recalls on record.
Top product codes for Codman & Shurtleff, Inc.
FDA recalls by Codman & Shurtleff, Inc.
10 most recent of 59- Z-2280-2019 — GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
- Z-1571-2014 — MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
- Z-1572-2014 — MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
- Z-1684-2015 — CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .
- Z-0090-2015 — Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Z-0089-2015 — Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Z-0091-2015 — Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Z-2184-2014 — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Z-2191-2014 — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Z-2189-2014 — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Codman & Shurtleff, Inc.
1–100 of 152- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
- K191237 — CERENOVUS Large Bore Catheter
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
- K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
- K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
- K171862 — GALAXY G3 Mini Microcoil Delivery System
- K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
- K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
- K162563 — YOGA Microcatheter
- K162437 — Codman EDS3 CSF External Drainage System
- K153347 — Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
- K152481 — DURAFORM Dural Graft Implant
- K150319 — MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
- K142429 — CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
- K140080 — ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
- K140307 — ENVOY GUIDING CATHETER
- K133625 — AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
- K132281 — ReVive PV (Peripheral Vasculature) Thrombectomy Device
- K123560 — VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
- K121776 — AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
- K122118 — HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
- K120117 — CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
- K120686 — ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
- K120229 — ENVOY DISTAL ACCESS GUIDING CATHETER
- K112828 — REVIVE INTERMEDIATE CATHETER (REVIVE IC)
- K110751 — CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
- K102961 — HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM
- K102589 — CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
- K093973 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K092437 — CODMAN STERILIZATION CONTAINERS
- K100351 — NEUROSCOUT STEERABLE GUIDEWIRE
- K093184 — ENVOY GUIDING CATHETERS
- K091921 — CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
- K083895 — CODMAN ISOCOOL BIPOLAR FORCEPS
- K091346 — CODMAN HAKIM MICRO II VALVE
- K090348 — CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
- K073336 — CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
- K071931 — CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
- K071791 — MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
- K071776 — ANEUROPLASTIC, MODEL 43-1290
- K061876 — CODMAN VPV SYSTEM, MODEL 82-3192
- K061568 — CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
- K053107 — CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
- K053350 — MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
- K052449 — CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
- K050739 — CODMAN VPV SYSTEM, MODEL 82-3192
- K041518 — CODMAN DURAFORM DURAL GRAFT IMPLANT
- K041296 — MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
- K033395 — CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
- K023566 — CODMAN ISOCOOL BIPOLAR FORCEPS
- K031123 — CODMAN BACTISEAL BARIUM STRIPED CATHETERS
- K021653 — CODMAN BACTISEAL EVD CATHETER SET
- K020667 — CODMAN HAKIM SHUNT SYSTEMS
- K013877 — CODMAN SLIM-LOC SYSTEM
- K003322 — CODMAN BACTISEAL CATHETERS
- K003549 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
- K003564 — HAKIM PROGRAMMER AND TRANSMITTER
- K002798 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
- K992905 — CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
- K992591 — CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
- K953568 — CODMAN FIDUCIAL MARKER SYSTEM
- K944612 — ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM
- K912456 — SUNDT SLIM-LINE GRAFT CLIPS
- K934756 — CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
- K934196 — CODMAN QUICK SHUNT KIT, CAT. #82-6570
- K914479 — MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
- K933894 — DISPOSABLE PERFORATOR
- K924977 — CODMAN LASER NEUROENDOSCOPE
- K931281 — MICRO ENDOSCOPIC ELECTRODE (ME2)
- K924242 — DISPOSABLE PERFORATOR
- K924142 — CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
- K923869 — CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
- K926116 — CODMAN SOFWIRE(TM) KIT
- K920979 — CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
- K923555 — CODMAN GAAB NEUROENDOSCOPE
- K923646 — CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
- K913987 — OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
- K915581 — CODMAN SOF'WIRE (TM) KIT
- K912005 — CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
- K911723 — CODMAN DISPOSABLE SKULL PINS
- K913170 — CODMAN SKULL CLAMP
- K911772 — GARDNER PINS (ADULT & CHILD)
- K910938 — CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II)
- K912011 — CODMAN SKULL CLAMP
- K913233 — CODMAN LHALO SPLIT RING RETRACTOR SYSTEM
- K911917 — CODMAN PEDIATRIC HORSESHOE HEADREST
- K911918 — SWIVEL HORSESHOE HEADREST
- K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER
- K904352 — CODMAN COLLINS RADIOPARENT STERNAL BLADES
- K904120 — ACCU-FLO* UNITIZED SHUNT
- K900881 — OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM
- K902544 — SUNDT AVM MICRO CLIP
- K902257 — CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
- K901937 — CODMAN SUCTION PATTIE
- K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
- K894756 — DENVER PERITONEO-VENUS SHUNT
- K892215 — UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
- K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
- K880570 — DENVER PLEURO-PERITONEAL SHUNT
- K880401 — DENVER PERITONEO-VENOUS SHUNT
Data sourced from openFDA. This site is unofficial and independent of the FDA.