Panels › General, Plastic Surgery › Product code GAA · Class 1
Needle, Aspiration And Injection, Disposable
Regulation 878.4800
0510(k)s in 12 months (107 all time)
0recalls in 12 months (37 all time)
5recalls that name a 510(k)
Top companies in GAA
| Company | 510(k)s | Recalls |
|---|---|---|
| A.D.T. Lab Industries | 14 | 0 |
| Vitreq Bv | 0 | 10 |
| Medical Device Technologies, Inc. | 3 | 3 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Dlp, Inc. | 5 | 0 |
| National Patent Development Corp. | 4 | 0 |
| R. J. Doyle, Inc. | 4 | 0 |
| Symbiosis Corp. | 4 | 0 |
| Hobbs Medical, Inc. | 1 | 2 |
| INNOVATIVE TOMOGRAPHY PRODUCT GMBH | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2023 | Tytek Medical Inc TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax
Model Number: TM-317 Terminated |
GAA | None listed |
| Sep 19, 2023 | Tytek Medical Inc TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax
Terminated |
GAA | None listed |
| Sep 19, 2023 | Tytek Medical Inc TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax
Mode Terminated |
GAA | None listed |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Transbronchial Aspiration Needle
Catalog Number: 4621 Open, Classified |
GAA | K860582 |
| Oct 7, 2022 | Hobbs Medical, Inc. Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Catalog Number: 4620 Open, Classified |
GAA | K860582 |
| Aug 27, 2021 | North American Rescue LLC. 10 ga ARS Decompression Needle, Part Number ZZ-0298 Terminated |
GAA | None listed |
| Aug 5, 2021 | M.D.L. S.r.l. Aspirated Cyto-Histological Biopsy needle Terminated |
GAA | None listed |
| Apr 21, 2021 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:
Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm);
Article no. BIM 18/15, Length 150 Open, Classified |
GAA | None listed |
| Apr 21, 2021 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:
Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm);
Article no. KIR 23/05N, Length 50 Open, Classified |
GAA | None listed |
| Apr 21, 2021 | INNOVATIVE TOMOGRAPHY PRODUCT GMBH Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:
Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm;
Article no. KIM 22/07,Length 75 mm, Open, Classified |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs. Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 27G Blunt Needles with luer-lock connector-REF:
CN27.D05
GTIN:8719214221669 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 25G Blunt Needles with luer-lock connector-REF :
CN25.D05
GTIN: 8719214221645 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 23G Blunt Needles with luer-lock connector-REF:
CN23.D05
GTIN: 8719214221621 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 25G Pick Needles-REF: CN25.D04
GTIN: 8719214221607 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 23G Pick Needles-REF: CN23.D04
GTIN: 8719214221584 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 25G PFC Injection Needle-Ref: MD25.D01
GTIN: 8719214221386 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 23G PFC Injection Needle- Ref: MD23.D01
GTIN: 8719214221362 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51
GTIN: 8719214221089
(2) VitreQ 20G BF Brush Needles-REF: BF20.D52
GTIN: 8719214221102 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv (1)VitreQ 25G BF Blunt Needles-BF25.D51
GITN: 8719214221164
(2) VitreQ 25G BF Brush Needles-BF25.D52
GTIN: 8719214221188 Terminated |
GAA | None listed |
| Dec 17, 2019 | Vitreq Bv (1) VitreQ 23G BF Blunt Needles-BF23.D51
GTIN#: 8719214221126
(2) VitreQ 23G BF Brush Needles-BF23.D52
GTIN#: 8719214221140 Terminated |
GAA | None listed |
| Aug 10, 2015 | Cadence Inc. Micro-Mate Tuberculin Glass Syringe, Non-sterile
Catalog numbers 5208, 5209 Terminated |
GAA | None listed |
| Aug 10, 2015 | Cadence Inc. Perfectum Tuberculin Glass Syringe, Non sterile
Catalog numbers 5202, 5205, 5212 Terminated |
GAA | None listed |
| Aug 27, 2013 | SpineNet SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M).
Use to aspirate bone morrow. Terminated |
GAA | None listed |
| Feb 8, 2011 | Inrad, Inc Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI.
The device is intended for use during percutaneous biopsy Terminated |
GAA | K813368 |
| Oct 7, 2010 | Becton Dickinson & Company BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106.
Needles are intended for use in aspiration and injection of medications. Terminated |
GAA | None listed |
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Breast Localization Needles:
A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE.
Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 51 Terminated |
GAA | K974741 |
| Sep 8, 2009 | Vital Signs Inc Broselow/Hinkle Pediatric Emergency System;
Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use,
INTRAOSSEU Terminated |
GAA | None listed |
| Sep 25, 2008 | Medical Device Technologies, Inc. Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions. Terminated |
GAA | None listed |
| Feb 19, 2008 | First Aid Only Inc Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA.
Ibuprofen Tablets, Item A405-WIP, Item A405-10
Ibuprofen Tablets, Terminated |
GAA | None listed |
| Jul 20, 2004 | Medical Device Technologies, Inc. BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioP Terminated |
GAA | None listed |
| Jul 20, 2004 | Enpath Medical, Inc. AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803 Terminated |
GAA | None listed |
| Jul 20, 2004 | Novosci Corp Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TX Terminated |
GAA | K801393 |
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