Surgical devices · 21 CFR 872 Subpart E
Surgical Biopsy Punch
FDA device type “Punch, Biopsy, Surgical”.
- Companies listing it
- 8057 makers
- Brands and models
- 109
- 510(k) clearances
- 30 in five years
- FDA name
- Punch, Biopsy, Surgical
510(k) clearances per year, 1976–2026
Companies that list EME
80 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Straumann Dental Implant System | 212 | 2026 |
| OT medical GmbH | Germany | Maker | Center Punch | 3 | 2016 |
| Storz AM Mark GmbH | Germany | Maker | Tissue punch | 2 | 2008 |
| Abracadabra Implants Ltd. | Israel | Maker | TP29 - Tissue Punch 2.9mm · TP35 - Tissue Punch 3.5mm · TP40 - Tissue Punch 4mm · TP50 - Tissue Punch 5mm · +2 | 1 | 2021 |
| Osung Mnd Co Ltd | South Korea | Maker | RDPN1 · RDPN1P · TP35 · TP40 · +16 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | tomas-punch | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Punch, Biopsy, Surgical | — | — |
| Commic Surgico | Pakistan | Maker | biopsy punch · Fue Punch · Fue Punch Serrated · Tissue Punches | — | — |
| Endo Tech Instruments | Pakistan | Maker | BACKBITING NASAL PUNCH .2.5MMX7MM · BACKBITING NASAL PUNCH PED, 1.5MMX5MM · BACKBITING NASAL PUNCH PEDROT, 1.5MMX5MM · BACKBITING NASAL PUNCH ROT.2.5MMX7MM | — | — |
| Medcave Private Limited | Pakistan | Maker | Punch | — | — |
| Panorama International | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Lacigrus International | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | GUM PUNCH | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EME / PUNCH, BIOPSY, SURGICAL | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Punch Forceps | — | — |
| Surgiscape | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EME - PUNCH, BIOPSY, SURGICAL | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | APEX BIOPSY PUNCH, 20CM · BABY TISCHLER BIOPSY PUNCH 8 1/2" · KEVORKIAN BIOPSY PUNCH, 20CM · MINI-TOWNSEND BIOPSY PUNCH, 20CM · +6 | — | — |
| Choose Surgical Instruments | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Teleflex | United States | Maker | MULTIPLE SURGICAL BIOPSY PUNCHES · PILLING | — | — |
| Trimed Pvt Ltd | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Mian Shahid Corp. | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Biopsy Forceps · Bone Punches | — | — |
| Nawaz and Sons | Pakistan | Maker | EME / PUNCH, BIOPSY, SURGICAL | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | — | — | — |
| Omnia SRL | United States | Maker | TISSUE PUNCH | — | — |
| Trinity Sterile Inc | United States | Maker | Biopsy · Kit | — | — |
| Greens Surgicals Private Limited | India | Maker | Dr. Vinay Kumar | — | — |
| Meister Surgical Instruments | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| IAA Surgical Instruments Co | Pakistan | Maker | Biopsy Forceps | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Princeton Medical Group, Inc. | United States | Maker | Princeton | — | — |
| Cooper Surgical Inc | United States | Maker | DISPOSA-DERM · Euro-Med Skin Punch · [Skin Punch] | — | — |
| DTR Medical Ltd | United Kingdom | Maker | Oral Rotating Biopsy Punch | — | — |
| Kazan Medical Instruments Plant Joint Stock Compan | Russia | Maker | Punch | — | — |
| Fischer Surgical Inc. | United States | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Meditec Devices | India | Maker | Gynex Keye's Punch · Tru-Punch-Sklar | — | — |
| Hospital Equipment MFG. Co. | India | Maker | HEMC | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Ribbel International Limited | India | Maker | RIBBEL | — | — |
| Surgimed Devices | India | Maker | Biopsy Punch | — | — |
| Suru International Pvt Ltd | India | Maker | SURU | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| Jai Surgicals Limited | India | Maker | — | — | — |
| Mclean Medical & Scientific | United States | Maker | — | — | — |
| Razormed Inc | India | Maker | — | — | — |
| REDA Instrumente GmbH | Germany | Maker | — | — | — |
| Schmid Medizintechnik GmbH | Germany | Maker | — | — | — |
| Track of Surgical | Pakistan | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | Punch | 94 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Basic Dental Implant Systems, Inc. | United States | Manufacturer | TISSUE PUNCH | 6 | 2008 |
| Summit Medical, LLC | United States | Lister | Oral Rotating Biopsy Punch | 1 | 2017 |
| Sotera Health LLC | United States | Contract manufacturer | Disposa-Derm · Skin Biopsies/Skin Punch Disposa-Derm | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| STERIS Corporation | United States | Contract sterilizer | Acuderm1463 (WH,LS) - Acu-Punch | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | PUNCHES | — | — |
| Sklar Corporation | United States | Repacker / relabeler | punch | — | — |
| Elmed, Inc. | United States | Repacker / relabeler | ELMED | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Andersen Caledonia Ltd | United Kingdom | Contract sterilizer | PUNCH, BIOPSY, SURGICAL | — | — |
| Shoney Scientific, Inc. | United States | Repacker / relabeler | Gynex Keye's Punch · Tru-Punch - Sklar | — | — |
| Hayden Medical | United States | Repacker / relabeler | Biopsy Punch | — | — |
| Xemax Surgical Products, Inc. | United States | Manufacturer | Accupunch | — | — |
| Gynex Corp. | United States | Repacker / relabeler | KEYES SKIN PUNCH | — | — |
| Elcon Medical Instruments GmbH | Germany | Repacker / relabeler | — | — | — |
| Microtrol Sterilisation Services Pvt. Ltd. | India | Contract sterilizer | — | — | — |
| Shriram Institute For Industrial Research | India | Contract sterilizer | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 7 Jan 1994 | K933670 | BIOPSY PUNCH, SURGICAL | Byron Medical |
| 9 Oct 1991 | K911285 | PULPDENT POLYAMIDE DENTIN LINER | Pulpdent Corporation |
| 6 Mar 1989 | K884740 | EURO-MED LIGHT TOUCH BIOPSY PUNCH | Buckman Co., Inc. |
Official records: FDA product classification for EME · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026