FDA Product Code
FDA Product Code MDM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 | Traditional | PDF ↗ |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 | Traditional | PDF ↗ |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 | Traditional | PDF ↗ |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | 2002-11-13 | Traditional | PDF ↗ |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 | Traditional | PDF ↗ |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 | Traditional | PDF ↗ |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 | Traditional | PDF ↗ |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 | Traditional | PDF ↗ |
| K933265 | ACU-DISPO-CE(TM) | Acuderm, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K933866 | ACU-HEMOSTATIC RING | Acuderm, Inc. | 1993-12-01 | Traditional | PDF ↗ |
| K925653 | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH | Dermatopathology Laboratory | 1993-11-08 | Traditional | PDF ↗ |
| K922130 | HOSPITAL KIT DK 117 | Savoy Medical Supply Co., Inc. | 1993-05-24 | Traditional | PDF ↗ |
| K926126 | SUTUREMATE | Surgical Safety Products, Inc. | 1993-05-19 | Traditional | PDF ↗ |
| K930775 | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC | Falcon Instruments, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K922127 | HOSPITAL KIT GP 103 | Savoy Medical Supply Co., Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K922128 | HOSPITAL KIT EP 104 | Savoy Medical Supply Co., Inc. | 1993-03-23 | Traditional | PDF ↗ |
| K925874 | BREAST STABILIZER | Bip USA, Inc. | 1993-03-16 | Traditional | PDF ↗ |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | O.R. Concepts, Inc. | 1993-02-17 | Traditional | PDF ↗ |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | American Biomaterials Corp. | 1993-02-05 | Traditional | PDF ↗ |
| K924503 | PERSONNA SAFETY SCALPEL | American Safety Razor Co. | 1993-02-05 | Traditional | PDF ↗ |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | Tri-State Hospital Supply Corp. | 1992-12-17 | Traditional | PDF ↗ |
| K921022 | DISPOSABLE CURETTE | Dermtec, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K921988 | LACERATION REPAIR TRAY | Cypress Medical Products, Ltd. | 1992-11-19 | Traditional | PDF ↗ |
| K921822 | FRAY BIO-PUNCH | Fray Products Corp. | 1992-10-28 | Traditional | PDF ↗ |
| K920296 | DISPOSABLE FORCEPS | Falcon Instruments, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K920297 | DISPOSABLE SCISSORS | Falcon Instruments, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K922874 | DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE | Supra Instruments, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K921210 | SURGICAL INSTRUMENT STAND | Murphy Medical Center | 1992-04-29 | Traditional | PDF ↗ |
| K911369 | QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER | Deroyal Industries, Inc. | 1991-05-13 | Traditional | PDF ↗ |
| K911895 | QUALTEX SUTURE BOOTIES | Deroyal Industries, Inc. | 1991-05-08 | Traditional | PDF ↗ |
| K905105 | JAIN SUTURE/VESIBAND ORGANIZER | Jain Surgical Equipment, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K905478 | YANKAUER SUCTION DEVICE | Medovations, Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K855132 | SHAVE PREP TRAY | Dynarex Corp. | 1986-01-24 | Traditional | PDF ↗ |
| K812691 | SILICONE IMPLANTS | Sutter Biomedical, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K801328 | THE EQUALIZER | The Anspach Effort, Inc. | 1980-06-09 | Traditional | PDF ↗ |
Product code MDM · Class I · General, Plastic Surgery. Data: openFDA.