Company ยท US
Ballard Medical Products
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2003. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 12 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 |
| GEC | Brush, Scrub, Operating-Room | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BYH | Drain, Tee (Water Trap) | 1 |
| BYI | Percussor, Powered-Electric | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FXX | Mask, Surgical | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| KPJ | Chamber, Oxygen, Topical, Extremity | 1 |
| KTR | Tube, Aspirating, Bronchoscope, Rigid | 1 |
| LRO | General Surgery Tray | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2003 | K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE Ballard Medical Products | LRO |
| Oct 11, 2002 | K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS Ballard Medical Products | BWH |
| Jul 11, 2002 | K013892 | LUTZ NEEDLE Ballard Medical Products | BSP |
| Mar 28, 2000 | K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES Ballard Medical Products | BSP |
| Oct 20, 1999 | K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT Ballard Medical Products | KNT |
| May 3, 1999 | K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME Ballard Medical Products | KNS |
| Sep 11, 1998 | K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT Ballard Medical Products | KNT |
| Mar 11, 1998 | K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN Ballard Medical Products | CAH |
| Feb 11, 1997 | K964369 | TRACH CARE SET WITH MICROBAN Ballard Medical Products | BSY |
| Jul 5, 1995 | K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT Ballard Medical Products | KDH |
| Jul 30, 1993 | K923487 | BAL CATH Ballard Medical Products | KTR |
| May 8, 1992 | K915109 | RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET Ballard Medical Products | FPA |
| Aug 29, 1990 | K900273 | TRACH CARE MDI ADAPTER Ballard Medical Products | CAF |
| Nov 15, 1989 | K895360 | C.P.A.P. VALVE AND C.P.P.A. KIT Ballard Medical Products | BYE |
| Nov 7, 1989 | K895130 | HEIMLICH MICRO TRACH Ballard Medical Products | BTO |
| Nov 28, 1988 | K882461 | O2 CARE Ballard Medical Products | KPJ |
| Jun 21, 1988 | K881790 | SAFETY DRAIN Ballard Medical Products | BYH |
| Jan 15, 1988 | K873731 | SAFETY SHIELD KIT Ballard Medical Products | FXX |
| Dec 11, 1987 | K873810 | SAFETY SHIELD SUCTION CATHETER Ballard Medical Products | BSY |
| Oct 13, 1987 | K873732 | TRACH CARE START KIT Ballard Medical Products | BSY |
| Sep 15, 1987 | K872621 | TRACH CARE CATHETER Ballard Medical Products | BSY |
| Aug 3, 1987 | K872283 | ORAL SUCTION CATHETER Ballard Medical Products | BSY |
| Feb 20, 1986 | K860510 | NEONATE PERCUSSOR Ballard Medical Products | BYI |
| Nov 16, 1984 | K843636 | FOAM CARE ONE STEP PREP Ballard Medical Products | GEC |
| May 16, 1983 | K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 Ballard Medical Products | GEC |
| Mar 26, 1982 | K820713 | BALLARD MEDICAL PRODUCTS ELECTRO-SURG Ballard Medical Products | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For distribution to Germany only. Terminated |
BSY | None listed |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution only. Terminated |
BSY | None listed |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates Terminated |
BSY | K872621 |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates Terminated |
BSY | K872621 |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates Terminated |
BSY | K872621 |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates Terminated |
BSY | K872621 |
| Aug 6, 2003 | Ballard Medical Products Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. Terminated |
BSY | K872621 |