Brush, Biopsy, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
17 adverse event reports on file
- HARRELL 7MM BRONCH BRUSH (20/CS)Apr 23, 2024MalfunctionConsolidated Medical Equipment Company3007305485-2024-00061
- HARRELL 7MM BRONCH BRUSH (20/CS)Mar 6, 2024MalfunctionConsolidated Medical Equipment Company3007305485-2024-00032
- HARRELL BRONCHOSCOPEMar 6, 2024MalfunctionConmed CorporationMW5152454
- WATS BIOPSY INSTRUMENT FOR COMPUTER ASSISTED 3D ANALYSISMay 16, 2022MalfunctionEndotherapeutics, Inc.1000132436-2022-00001
- MARKED GUIDEWIRE (2/CS)Nov 7, 2021InjuryConsolidated Medical Equipment Company3007305485-2021-00409
- N/AOct 13, 2021MalfunctionConmed Corporation12623187
- MARKED GUIDEWIRE (2/CS)Sep 1, 2021MalfunctionConsolidated Medical Equipment Company3007305485-2021-00363
- MARKED GUIDEWIRE (2/CS)Aug 30, 2021MalfunctionConsolidated Medical Equipment Company3007305485-2021-00343
- CLEANGUIDEJun 29, 2021MalfunctionConmed Corporation12083431
- REUSABLE MARKED SPRING TIP GUIDEWIREOct 29, 2020MalfunctionConmed Corporation10754814
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
42 firms currently registered for this product code
Goodwood Medical Care Ltd
Dalian Liaoning, CN
Synergy Health Ede Bv
Venlo Limburg, NL
Evonos Gmbh & Co. Kg
Tuttlingen Baden-Wurttemberg, DE
Jiangsu Suyun Medical Materials Co., Ltd.
Lianyungang Jiangsu, CN
Sinntech Medical (private) Limited
Sialkot Punjab, PK
Isomedix Operations Inc.
S Plainfield, NJ, US
Dongguan City Ruimi Gift Products Co Ltd
Dongguan Guangdong, CN
Rovers Medical Devices B.v.
OSS Noord-Brabant, NL
Labchem Sdn. Bhd
PETALNG JAYA Selangor, MY
Millennium Surgical Corp
Schaumburg, IL, US
Elmed, Inc.
Glendale Heights, IL, US
Conmed Corporation
WESTBOROUGH, MA, US
Isomedix Operations, Inc
ONTARIO, CA, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hobbs Medical, Inc.
Stafford Springs, CT, US
Histologics Llc
Anaheim, CA, US
Sterigenics U.s., Llc
Santa Teresa, NM, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Ningbo Tianbo First Aid Product Co., Ltd.
Ningbo Zhejiang, CN
Endo-therapeutics, Inc.
CLEARWATER, FL, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Conmed Corporation
Utica, NY, US
Consolidated Medical Equipment Company
Chihuahua, MX
510(k) clearances
7 clearances for this product code
- Co-Medical, Inc.Oct 18, 1985
K854003 · STERILE SOFT TISSUE BIOPSY NEEDLE
- Premier Dental Products Co.Jun 8, 1984
K841008 · BIOPSY PUNCH, VARIOUS
- Van-Tec, Inc.Sep 14, 1982
K822490 · DEFLECTING CYTOLOGY BRUSH
- American Endoscopy, Inc.Mar 5, 1982
K820259 · STERILE CYTOLOGY BRUSHES
- Medi-SpecOct 26, 1981
K812694 · WHISK-R
- Johannah Medical Services, Inc.Jun 17, 1980
K801304 · CAMLOC SYRINGE BIOPSY KIT
- Ursus Konsult ABDec 18, 1979
K792316 · TROTEX II SCREW NEEDLE BIOPSY INSTR. SET