Panels › General, Plastic Surgery › Product code MDM · Class 1
Instrument, Manual, Surgical, General Use
Regulation 878.4800
0510(k)s in 12 months (44 all time)
1recalls in 12 months (77 all time)
3recalls that name a 510(k)
Top companies in MDM
| Company | 510(k)s | Recalls |
|---|---|---|
| Ethicon Endo-Surgery | 0 | 38 |
| Stryker Spine | 0 | 14 |
| Biomet, Inc. | 0 | 5 |
| Savoy Medical Supply Co., Inc. | 4 | 0 |
| Falcon Instruments, Inc. | 3 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 3 |
| Acuderm, Inc. | 2 | 0 |
| Applied Medical Resources Corp | 0 | 2 |
| Deroyal Industries, Inc. | 2 | 0 |
| Trilliant Surgical Ltd. | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2008 | K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER Injectimed, Inc. | MDM |
| Aug 15, 2005 | K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM Futumeds Sdn Bhd, MY | MDM |
| May 18, 2005 | K050957 | EUTROCHAR Special Devices, Inc. | MDM |
| Dec 18, 2002 | K023173 | ANDREWS INTRODUCER, MODEL ASI01 Andrews Surgical Innovations, Ltd., IE | MDM |
| Nov 13, 2002 | K022059 | MICROVASIVE PULMONARY GUIDEWIRE Boston Scientific Corp | MDM |
| Dec 7, 2001 | K013040 | LIGHT SABER INTRODUCER NEEDLE Minrad, Inc. | MDM |
| Jun 22, 2001 | K010184 | CHESS HAND SURGERY SYSTEM Canica Design, Inc., CA | MDM |
| Mar 30, 1999 | K990062 | SAPHLIFT Genzyme Surgical Product (Genzyme Biosurgery) | MDM |
| Jul 9, 1998 | K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG ETHICON, Inc. | MDM |
| Mar 1, 1995 | K943968 | TUNNELER Denver Biomedicals, Inc. | MDM |
| Nov 28, 1994 | K945430 | DERMAVBLADE(TM) Hasting'S Biomedical Corp. | MDM |
| Nov 9, 1994 | K941193 | EAST WEST INSTRUMENTS East West Instruments, Inc. | MDM |
| Aug 26, 1994 | K941907 | APEX DISPOSABLE INSTRUMENTS Apex Ent., Inc. | MDM |
| Aug 25, 1994 | K942818 | DEEP SUTURE Automated Medical Products Corp. | MDM |
| Jul 19, 1994 | K942896 | CLAMPS AND CLIPS Surgin Surgical Instrumentation, Inc. | MDM |
| Mar 14, 1994 | K940684 | SURGICAL INSTRUMENT, DISPOSABLE Her-Mar, Inc. | MDM |
| Mar 7, 1994 | K933265 | ACU-DISPO-CE(TM) Acuderm, Inc. | MDM |
| Dec 1, 1993 | K933866 | ACU-HEMOSTATIC RING Acuderm, Inc. | MDM |
| Nov 8, 1993 | K925653 | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH Dermatopathology Laboratory, AU | MDM |
| May 24, 1993 | K922130 | HOSPITAL KIT DK 117 Savoy Medical Supply Co., Inc. | MDM |
| May 19, 1993 | K926126 | SUTUREMATE Surgical Safety Products, Inc. | MDM |
| Apr 23, 1993 | K930775 | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC Falcon Instruments, Inc. | MDM |
| Mar 29, 1993 | K922127 | HOSPITAL KIT GP 103 Savoy Medical Supply Co., Inc. | MDM |
| Mar 26, 1993 | K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT Savoy Medical Supply Co., Inc. | MDM |
| Mar 23, 1993 | K922128 | HOSPITAL KIT EP 104 Savoy Medical Supply Co., Inc. | MDM |
| Mar 16, 1993 | K925874 | BREAST STABILIZER Bip USA, Inc. | MDM |
| Feb 17, 1993 | K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER O.R. Concepts, Inc. | MDM |
| Feb 5, 1993 | K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS American Biomaterials Corp. | MDM |
| Feb 5, 1993 | K924503 | PERSONNA SAFETY SCALPEL American Safety Razor Co. | MDM |
| Dec 17, 1992 | K923812 | CENTURION DISPOSABLE INSTRUMENTS Tri-State Hospital Supply Corp. | MDM |
| Dec 3, 1992 | K921022 | DISPOSABLE CURETTE Dermtec, Inc. | MDM |
| Nov 19, 1992 | K921988 | LACERATION REPAIR TRAY Cypress Medical Products, Ltd. | MDM |
| Oct 28, 1992 | K921822 | FRAY BIO-PUNCH Fray Products Corp. | MDM |
| Sep 11, 1992 | K922874 | DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE Supra Instruments, Inc. | MDM |
| Sep 11, 1992 | K920297 | DISPOSABLE SCISSORS Falcon Instruments, Inc. | MDM |
| Sep 11, 1992 | K920296 | DISPOSABLE FORCEPS Falcon Instruments, Inc. | MDM |
| Apr 29, 1992 | K921210 | SURGICAL INSTRUMENT STAND Murphy Medical Center | MDM |
| May 13, 1991 | K911369 | QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER Deroyal Industries, Inc. | MDM |
| May 8, 1991 | K911895 | QUALTEX SUTURE BOOTIES Deroyal Industries, Inc. | MDM |
| Jan 31, 1991 | K905105 | JAIN SUTURE/VESIBAND ORGANIZER Jain Surgical Equipment, Inc. | MDM |
| Dec 19, 1990 | K905478 | YANKAUER SUCTION DEVICE Medovations, Inc. | MDM |
| Jan 24, 1986 | K855132 | SHAVE PREP TRAY Dynarex Corp. | MDM |
| Nov 16, 1981 | K812691 | SILICONE IMPLANTS Sutter Biomedical, Inc. | MDM |
| Jun 9, 1980 | K801328 | THE EQUALIZER The Anspach Effort, Inc. | MDM |
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