FDA Device Registration & Listing · AGUA PRIETA Sonora, MX · Registration 9680215
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 2010-02-23 |
| LGF | Component, Cast | Orthopedic | Class 1 | 888.5940 | 2014-12-08 |
| JAY | Support, Breathing Tube | Anesthesiology | Class 1 | 868.5280 | 2009-06-18 |
| BZQ | Monitor, Breathing Frequency | Anesthesiology | Class 2 | 868.2375 | 2023-09-05 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2023-09-05 |
| DQA | Oximeter | Cardiovascular | Class 2 | 870.2700 | 2023-09-05 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | Class 2 | 870.2910 | 2023-09-05 |
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | Class 2 | 870.2300 | 2023-09-05 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2011-07-07 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2020-07-09 |
| EYJ | Holder, Ureteral Catheter | Gastroenterology, Urology | Class 1 | 876.5130 | 2010-06-16 |
| NPF | Monitor, Apnea, Home Use | Anesthesiology | Class 2 | 868.2377 | 2015-12-20 |
| KMI | Monitor, Bed Patient | General Hospital | Class 1 | 880.2400 | 2019-12-18 |
| FMQ | Restraint, Protective | General Hospital | Class 1 | 880.6760 | 2013-08-06 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | Class 2 | 868.5895 | 2014-12-08 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-12-19 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2018-12-19 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2018-12-19 |
| OOG | Knee Arthroplasty Implantation System | Orthopedic | Class 2 | 888.3560 | 2018-12-19 |
| FOK | Pad, Neonatal Eye | General Hospital | Class 1 | 880.5270 | 2012-07-27 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2017-12-14 |
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2004-01-28 |
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | Class 2 | 884.2740 | 2010-04-13 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2004-01-28 |
| IKX | Aid, Transfer | Physical Medicine | Class 1 | 890.5050 | 2004-01-28 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2013-07-01 |
| IPW | Orthosis, Sacroiliac, Soft | Physical Medicine | Class 1 | 890.3490 | 2020-12-18 |
| FSR | Light, Headband, Surgical | Ophthalmic | Class 2 | 886.4335 | 2014-12-08 |
| NPF | Monitor, Apnea, Home Use | Anesthesiology | Class 2 | 868.2377 | 2015-12-20 |
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | Class 2 | 868.5905 | 2019-12-18 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K913749 | Edentec Corp. | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | 1992-07-02 |
| K771407 | Research Development Corp. | LUNG VOLUME & PRESSURE MONITOR | 1977-08-04 |
| K122223 | Philips Medizin Systeme Boeblingen GmbH | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | 2013-04-12 |
| K071802 | Mammendorfer Institut Fur Physik Und Medizin GmbH | TESLA GUARD, MODEL EFT G04 | 2007-11-09 |
| K124061 | Invivo Corporation | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | 2013-02-22 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2015 | Invivo Corporation | 2 | Philips Expression MR200 MRI Patient Monitoring System Model 866120 |
| Z-0004-2023 | Philips North America Llc | 2 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561
This is a component of product number 866162. |
| Z-0011-04 | GE Medical Systems Information Technologies | 2 | Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug. |
| Z-0042-2015 | Mckesson Information Solutions LLC | 2 | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. |
| Z-2183-2011 | Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom | 2 | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT.
Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2032003 | AMERICAN PACIFIC PLASTIC FABRICATORS, INC. | Westminster, CA, US |
| 8040233 | QSA SURGICAL (PVT) LTD. | SIALKOT Punjab, PK |
| 3010331645 | Arthrex, Inc. | Ave Maria, FL, US |
| 1043572 | STERIS CORPORATION | MONTGOMERY, AL, US |
| 3014623126 | BioThane Coated Webbing Corp | North Olmsted, OH, US |
9680215 when referencing this establishment in official correspondence.