Biosearch Medical Products, Inc.
Concord, NC, US
BIOSEARCH MEDICAL PRODUCTS, INC. appears in FDA device records in Concord, NC. FDA records list 70 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 70FDA records hold 70 510(k) clearances for Biosearch Medical Products, Inc. between 1978 and 2005. The busiest year on record is 1990, with 14. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 4 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 10 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 14 |
| 1991 | 4 |
| 1992 | 5 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 2 |
| 1997 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051480 | ENTERAL FEEDING TUBE | BSS | Substantially Equivalent | |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | HIR | Substantially Equivalent | |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | FEB | Substantially Equivalent | |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | KOD | Substantially Equivalent | |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | FDX | Substantially Equivalent | |
| K932295 | NON-BALLOON REPLACEMENT GASTROSTOMY KIT | KNT | Substantially Equivalent | |
| K935045 | BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER | KNT | Substantially Equivalent | |
| K923002 | ENTEROCLYSIS TUBE | KNT | Unknown | |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | EOX | Substantially Equivalent | |
| K922987 | LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. | GCJ | Substantially Equivalent | |
| K923474 | LOW PROFILE GASTROMSTOMY DEVICE | KNT | Unknown | |
| K922765 | BIOSTARS STREP A OIA -- MODIFICATION | GTY | Substantially Equivalent | |
| K921029 | DOBBHOFF BIPOLAR ADAPTER | KNS | Substantially Equivalent | |
| K913736 | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST | FAP | Substantially Equivalent | |
| K915758 | STREP A OIA | GTZ | Substantially Equivalent | |
| K913784 | DOBBHOFF(R) SINGLE PASS PEG KIT | KNT | Unknown | |
| K914482 | STOMA MEASURING DEVICE | FPD | Substantially Equivalent | |
| K912889 | OIA STREP A | GTZ | Substantially Equivalent | |
| K913073 | DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT | FGE | Substantially Equivalent | |
| K912129 | DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE | KNS | Substantially Equivalent | |
| K903662 | PEEWEE REPLACEMENT GASTROSTOMY TUBE | KNT | Unknown | |
| K902843 | BIOSEARCH ANAL BIOFEEDBACK DEVICE | FAP | Substantially Equivalent | |
| K902236 | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT | GGW | Substantially Equivalent | |
| K900624 | DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM | KNT | Substantially Equivalent | |
| K900590 | BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING | KNT | Substantially Equivalent | |
| K900563 | DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH | KNT | Substantially Equivalent | |
| K900324 | DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE | KNT | Substantially Equivalent | |
| K901744 | DOBBHOFF(R) RETRIEVAL FORCEPS | KQW | Substantially Equivalent | |
| K901582 | DOBBHOFF BILIARY STENT SET | FGE | Substantially Equivalent | |
| K901322 | DOBBHOFF(R) POLYPECTOMY SNARE | FDI | Substantially Equivalent | |
| K901924 | READS(R) ANTI-ENA (SM/RNP) TEST KIT | LLL | Substantially Equivalent | |
| K901230 | REAADS ANTI-SM TEST KIT | LLL | Substantially Equivalent | |
| K896612 | DOBBHOFF(R) PAPILLOTOME | KNS | Substantially Equivalent | |
| K896518 | DOBBHOFF(R) ERCP CANNULA | FGE | Substantially Equivalent | |
| K894857 | PEDI-TUBE(R) STYLET | KNT | Substantially Equivalent | |
| K892445 | REAADS-RF TEST KIT-SEMIQUANTITATIVE | DHR | Substantially Equivalent | |
| K892444 | REAADS-RF TEST KIT-QUANTITATIVE | DHR | Substantially Equivalent | |
| K884309 | NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT | KNT | Substantially Equivalent | |
| K883587 | BIOSEARCH 3600 ENTRI FEEDING PUMP | FRN | Substantially Equivalent | |
| K880232 | NH REPLACEMENT GASTROSTOMY KIT | KNT | Substantially Equivalent | |
| K871528 | ENTRIMIT GRAVITY FEEDING SET | KNT | Substantially Equivalent | |
| K864182 | ENTERAL ADMINISTRATION ADAPTERS | KNT | Substantially Equivalent | |
| K854514 | AMBI-24 PH/PRESSURE MONITOR | FFT | Substantially Equivalent | |
| K850664 | ENDO-TUBE | KNT | Substantially Equivalent | |
| K850134 | ENTRON ENTERAL FEEDING BAG | KNT | Substantially Equivalent | |
| K850074 | ESOPHOGEAL PH CATHETER | FFT | Substantially Equivalent | |
| K844222 | BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR | KNT | Substantially Equivalent | |
| K843168 | ENTERAL FEEDING PUMP 14-800 SERIES | FRN | Substantially Equivalent | |
| K840936 | NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT | KNT | Substantially Equivalent | |
| K834268 | ISLAMI GASTROINTESTINAL TUBE | KNT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242547 | 2242547 | BIOSEARCH MEDICAL PRODUCTS, INC. | 4715 CORPORATE DR. NW SUITE 200, Concord, NC 28027 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- KODCatheter, Urological
- DLGCoating, Liquid, Glc
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FFTElectrode, Ph, Stomach
- FDXEndoscopic Cytology Brush
- EOXEsophagoscope (Flexible Or Rigid)
- LLLExtractable Antinuclear Antibody, Antigen And Control
- KQWGoniometer, Nonpowered
- FZXGuide, Surgical, Instrument
- GCJLaparoscope, General & Plastic Surgery
- HIRPerineometer
- FRNPump, Infusion
- FDISnare, Flexible
- FGEStents, Drains And Dilators For The Biliary Ducts
- FFXSystem, Gastrointestinal Motility (Electrical)
- DHRSystem, Test, Rheumatoid Factor
- GGWTest, Time, Partial Thromboplastin
- FPDTube, Feeding
- BSSTube, Nasogastric
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
