MDM

Injury

247

Malfunction

1,516

Total

1,763

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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