# Pro Med Instruments GmbH

- Location (FDA's records): Freiburg, DE
- FDA decisions: 10 (2000–2024): 10 510(k) clearances
- Names in FDA's records: Pro Med Instruments GmbH (6); Pro-Med Instruments GmbH (4)
- Product codes: HBL (9), GEI (1)
- Predicates its devices cite: 17 (8 its own); citations of its devices by later devices: 13 (8 its own)
- Recalls linked to its devices: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ohio Medical Instrument Co., Inc.: 3 (https://510kreport.com/company/ohio-medical-instrument)
- Guenter Bissinger Medizintechnik GmbH: 1 (https://510kreport.com/company/guenter-bissinger-medizintechnik)
- Silverglide Surgical Technologies: 1 (https://510kreport.com/company/silverglide-surgical-technologies)
- Acucera, Inc.: 1 (https://510kreport.com/company/acucera)
- Codman & Shurtleff, Inc.: 1 (https://510kreport.com/company/codman-shurtleff)
- Tz Medical, Inc.: 1 (https://510kreport.com/company/tz-medical)
- Dinkler Surgical Devices, Inc.: 1 (https://510kreport.com/company/dinkler-surgical-devices)

## Firms that cite its devices most
- Imris, Inc.: 2 (https://510kreport.com/company/imris)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Stingray Surgical Products, Inc.: 1 (https://510kreport.com/company/stingray-surgical-products)
- Medicon EG: 1 (https://510kreport.com/company/medicon-eg)

## Its most-cited devices
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components (2007), cited by 4
- K001808: Doro Headrest System (2000), cited by 3
- K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy) (2003), cited by 3
- K070997: Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX (2007), cited by 1
- K191740: DORO LUCENT® iXI and iMRI Headrest System (2020), cited by 1
- K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (2020), cited by 1

## Recent decisions
- K241883: DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)  (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs)  (3006-50) (Jul 26, 2024)
- K240319: DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) (Apr 24, 2024)
- K203505: DORO QR3 Headrest System (Aluminum) (Mar 29, 2021)
- K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (Jun 2, 2020)
- K191740: DORO LUCENT® iXI and iMRI Headrest System (Feb 21, 2020)
- K191979: DORO QR3 XTom Headholder System (Oct 22, 2019)
- K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components (May 21, 2007)
- K070997: Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX (May 16, 2007)

Source page: https://510kreport.com/company/pro-med-instruments