Medical Device Manufacturer · US , Rockville , MD

Bowen & Company, Inc.

14 submissions · 14 cleared · Since 1985
14
Total
14
Cleared
0
Denied

Bowen & Company, Inc. — FDA 510(k) Submissions

Bowen & Company, Inc. has submitted 14 FDA 510(k) premarket notifications since 1985, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Passer, Wire, Orthopedic, Instrument, Cutting, Orthopedic, Electrode, Electrocardiograph, Gauge, Depth, Instrument, Dental, Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
BOWEN ELECTRODE SKIN PREPATORY CLEANSER
K896898 · LKB Pad, Alcohol, Device... · General Hospital
Apr 1990 117d
DISPOSABLE 45 DEGREE SHAVER
K896538 · HRX Arthroscope · Orthopedic
Dec 1989 20d
STERNAL POWER AWL
K873766 · KIJ Instrument, Surgical,... · Orthopedic
Nov 1988 425d
CREMEEN ALVEOLAR BONE CALIPER
K872098 · EIL Gauge, Depth, Instrument,... · Dental
Jul 1987 60d
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K871325 · DRX Electrode,... · Cardiovascular
Jun 1987 66d
LOOSE BODY GRASPERS
K870881 · HTD Forceps · General & Plastic Surgery
Mar 1987 18d
45 DEGREE SHAVER
K870882 · HTZ Instrument, Cutting,... · General & Plastic Surgery
Mar 1987 18d
BOWEN SUTURE PASSER
K863146 · HXI Passer, Wire, Orthopedic · Orthopedic
Sep 1986 21d
GLENOID DRILL
K863147 · HTW Bit, Drill · Orthopedic
Sep 1986 21d
BOWEN KNOT PASSER
K863148 · HXI Passer, Wire, Orthopedic · Orthopedic
Sep 1986 21d
BOWEN PROBE
K863149 · HXB Probe · Orthopedic
Sep 1986 21d
BOWEN CANNULA
K863150 · GEA Cannula, Surgical,... · General & Plastic Surgery
Sep 1986 21d
MORGAN SUTURE-DRILL
K853376 · HWE Instrument, Surgical,... · Orthopedic
Nov 1985 93d
MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
K853601 · GAC Rasp, Surgical, General &... · General & Plastic Surgery
Sep 1985 20d
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