Company ยท US
Hu-Friedy Mfg. Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2012. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2012 | K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE Hu-Friedy Mfg. Co., LLC | EJI |
| Mar 30, 2010 | K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM Hu-Friedy Mfg. Co., Inc. | ELC |
| Feb 27, 2008 | K073369 | EI DOWNPAK BARRIER SLEEVES Hu-Friedy Mfg. Co., Inc. | EKM |
| Jun 21, 2007 | K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES Hu-Friedy Mfg. Co., Inc. | ELC |
| Feb 1, 2006 | K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS Hu-Friedy Mfg. Co., Inc. | ELC |
| Jul 27, 2001 | K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT Hu-Friedy Mfg. Co., Inc. | ELC |
| Oct 7, 1995 | K953919 | DENTAL ULTRASONIC SCALER INSERTS Hu-Friedy Mfg. Co., Inc. | ELC |
| Jul 24, 1991 | K912473 | ACCU-PLACER TM KIT Hu-Friedy Mfg. Co., Inc. | EKJ |
| Nov 8, 1984 | K844002 | HU-FRIEDY IMS CASSETTE SYSTEM Hu-Friedy Mfg. Co., Inc. | FSM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2005 | Hu-Friedy Mfg Co, Inc. Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B0 Terminated |
EKB | None listed |
| Feb 4, 2005 | Hu-Friedy Mfg Co, Inc. Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. T Terminated |
EKB | None listed |
| Feb 4, 2005 | Hu-Friedy Mfg Co, Inc. Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. Terminated |
EKB | None listed |
| Feb 4, 2005 | Hu-Friedy Mfg Co, Inc. Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. Pr Terminated |
EKB | None listed |
| Jul 20, 2004 | Hu-Friedy Mfg Co, Inc. HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCH Terminated |
EKB | None listed |
| Jul 20, 2004 | Hu-Friedy Mfg Co, Inc. HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY Terminated |
EKB | None listed |
| Jul 20, 2004 | Hu-Friedy Mfg Co, Inc. HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, IN Terminated |
EKB | None listed |
| May 9, 2003 | Hu-Friedy Mfg Co, Inc. Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618 Terminated |
GAB | None listed |