Doctor'S Research Group, Inc.
Wolcott, CT, US
Doctor'S Research Group, Inc. appears in FDA device records in Wolcott, CT. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Doctor'S Research Group, Inc. between 1998 and 2009. The busiest year on record is 1998, with 3. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091382 | KRYPTONITE BONE CEMENT | GXP | Unknown | |
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | KHJ | Substantially Equivalent | |
| K041018 | DRG SOFTRELEASE | HHT | Substantially Equivalent | |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | HIB | Substantially Equivalent | |
| K012003 | DRG REACTION CHAMBER/SAFETY TIP | HEI | Substantially Equivalent | |
| K011736 | DRG QUICKMIX | GXP | Substantially Equivalent | |
| K013786 | DRG ORTHOHEX SS BONE SCREW | HWC | Substantially Equivalent | |
| K002047 | DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 | DQD | Substantially Equivalent | |
| K991714 | DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 | DQD | Substantially Equivalent | |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | DYX | Substantially Equivalent | |
| K990920 | DRG TITANIUM BONE PLATE | JEY | Substantially Equivalent | |
| K981881 | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING | DZL | Substantially Equivalent | |
| K982169 | SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) | MBI | Substantially Equivalent | |
| K974817 | DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM | DZL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- DYXLock, Wire, And Ligature, Intraoral
- GXPMethyl Methacrylate For Cranioplasty
- HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic
- JEYPlate, Bone
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HHTSpatula, Cervical, Cytological
- HIBSpeculum, Vaginal, Nonmetal
- DQDStethoscope, Electronic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1496-2012 | Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects | Bone cement strength and stiffness fall below specification at body temperature | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
