Medical Device Manufacturer · US , Roswell , GA

Pro-Med Instruments GmbH

10 submissions · 10 cleared · Since 2000
10
Total
10
Cleared
0
Denied

Pro-Med Instruments GmbH — FDA 510(k) Submissions

Pro-Med Instruments GmbH has submitted 10 FDA 510(k) premarket notifications since 2000, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Holder, Head, Neurosurgical (skull Clamp), Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
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)
K241883 · HBL Holder, Head,... · Neurology
Jul 2024 28d
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
K240319 · HBL Holder, Head,... · Neurology
Apr 2024 82d
DORO QR3 Headrest System (Aluminum)
K203505 · HBL Holder, Head,... · Neurology
Mar 2021 119d
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
K193438 · HBL Holder, Head,... · Neurology
Jun 2020 174d
DORO LUCENT? iXI and iMRI Headrest System
K191740 · HBL Holder, Head,... · Neurology
Feb 2020 235d
DORO QR3 XTom Headholder System
K191979 · HBL Holder, Head,... · Neurology
Oct 2019 90d
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
K063494 · HBL Holder, Head,... · Neurology
May 2007 182d
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
K070997 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2007 37d
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
K032331 · HBL Holder, Head,... · Neurology
Nov 2003 114d
DORO HEADREST SYSTEM
K001808 · HBL Holder, Head,... · Neurology
Aug 2000 50d
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