37 results
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64ms
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Sources: EU EUDAMED, US FDA
G-TECH MEDICAL Inc.
FDA registration
G-TECH MEDICAL Inc.·1 product·🇺🇸 United States
GutTracker
FDA UDI
G-TECH MEDICAL, INC.·00860011391500·GutTracker measures GI motility of the stomach,...
SFTWR MMT-8060 INPEN APP IOS
FDA Adverse Event
Malfunction
·COMPANION MEDICAL INC·Product code NDC·August 20, 2023
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
FDA Enforcement
Class II
·Ongoing·UNIMAX MEDICAL SYSTEMS INC·September 25, 2024
*
FDA Adverse Event
Malfunction
·M-TECH MEDICAL, INC·Product code NNI·April 29, 2014
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
FDA Recall
Open, Classified
·UNIMAX MEDICAL SYSTEMS INC 8F-2, NO·Product code GCJ·June 25, 2024
Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.
FDA Recall
Completed
·Alliance Tech Medical, Inc·Product code CAH·October 6, 2014
Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.
FDA Enforcement
Class II
·Completed·Alliance Tech Medical, Inc·December 25, 2019
COMPANION 5
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·July 14, 2022
ECLIPSE 5
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·June 4, 2020
ECLIPSE 5
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·May 28, 2020
ECLIPSE 5
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·June 4, 2020
ECLIPSE 5
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·June 11, 2020
FREESTYLE COMFORT
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·September 1, 2022
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code MJP·December 5, 2023
VISIONAIRE
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·November 29, 2017
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012