Company ยท US
Instrument Makar, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2000. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 |
| JDR | Staple, Fixation, Bone | 2 |
| JOS | Electrode, Electrosurgical | 2 |
| KYZ | Syringe, Irrigating (Non Dental) | 2 |
| LYU | Accessory, Surgical Apparel | 2 |
| FWZ | Operating Room Accessories Table Tray | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| GCS | Endoscope, Battery-Powered And Accessories | 1 |
| GDF | Guide, Needle, Surgical | 1 |
| GDX | Scalpel, One-Piece | 1 |
| GDZ | Handle, Scalpel | 1 |
| HRX | Arthroscope | 1 |
| HWQ | Passer | 1 |
| HXB | Probe | 1 |
| HXJ | Staple Driver | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| LXI | Guide, Drill, Ligament | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2000 | K002600 | LITWIN CRUICATE ANCHOR Instrument Makar, Inc. | MBI |
| Nov 6, 1998 | K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT Instrument Makar, Inc. | JWH |
| May 6, 1997 | K963396 | BIOSPHERE SUTURE ANCHOR Instrument Makar, Inc. | MAI |
| Feb 25, 1997 | K964364 | DISPOSABLE APRON Instrument Makar, Inc. | LYU |
| Nov 19, 1996 | K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH Instrument Makar, Inc. | FXP |
| Jul 9, 1996 | K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR Instrument Makar, Inc. | MAI |
| Jul 31, 1995 | K943249 | BIOABSORBABLE INTERFERENCE SCREW Instrument Makar, Inc. | MAI |
| Feb 23, 1995 | K944062 | LAPRASCOPIC GRASPER Instrument Makar, Inc. | GCS |
| Feb 23, 1995 | K942828 | MAKAR FULL AND HALF FACE SHIELD Instrument Makar, Inc. | LYU |
| Feb 10, 1994 | K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW Instrument Makar, Inc. | HWC |
| Oct 27, 1993 | K923841 | BONE SCREWS Instrument Makar, Inc. | HWC |
| Nov 22, 1991 | K912021 | MAKAR MINI CANNULATED CANCELLOUS SCREWS Instrument Makar, Inc. | HWC |
| Mar 12, 1991 | K910723 | BIODEGRADABLE SURGICAL STAPLE Instrument Makar, Inc. | JDR |
| Feb 6, 1991 | K905365 | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM Instrument Makar, Inc. | KYZ |
| Aug 29, 1990 | K902854 | GRAVITY ASSIST Instrument Makar, Inc. | KYZ |
| Mar 22, 1989 | K890973 | STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE Instrument Makar, Inc. | JOS |
| Mar 22, 1989 | K890972 | HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE Instrument Makar, Inc. | JOS |
| Feb 9, 1989 | K885311 | MENISCUS MENDER II LOOP Instrument Makar, Inc. | HWQ |
| Sep 6, 1988 | K882407 | BOW & ARROW DRILL GUIDE Instrument Makar, Inc. | LXI |
| Sep 23, 1985 | K853597 | INSTRUMENT MAKAR DISPOSALBE LOOP Instrument Makar, Inc. | KDC |
| Dec 12, 1983 | K832978 | MENISCAL SUTURE GUN Instrument Makar, Inc. | GDF |
| Mar 9, 1983 | K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS Instrument Makar, Inc. | HXJ |
| Mar 9, 1983 | K830455 | STAPLES DESIGNED FOR ARTHROSCOPIC SURG Instrument Makar, Inc. | JDR |
| Jul 22, 1982 | K821847 | I.M. ARTHROSCOPE Instrument Makar, Inc. | HRX |
| Apr 3, 1981 | K810720 | I.M. SCALPEL HANDLE Instrument Makar, Inc. | GDZ |
| Mar 5, 1980 | K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS Instrument Makar, Inc. | HXB |
| Feb 11, 1980 | K800177 | I.M. BLADES Instrument Makar, Inc. | GDX |
| May 14, 1979 | K790674 | THE SURGICAL ASSISTANT Instrument Makar, Inc. | FWZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||