Microtek Medical, Inc.
Microtek Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2011, with 22 FDA device recalls on record.
Top product codes for Microtek Medical, Inc.
FDA recalls by Microtek Medical, Inc.
10 most recent of 22- Z-1963-2025 — Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.
- Z-2641-2024 — Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2642-2024 — Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2643-2024 — Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2640-2024 — Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2639-2024 — C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Z-2250-2023 — Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.
- Z-2251-2023 — Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-sterile; (5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile; (6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile; (7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile; (8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile; (9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile; (10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile; (11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile; (12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile; (13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile; (14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile; (15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile; (16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile; (17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and (18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile.
- Z-1071-2022 — TMJ Arthroscopy Drape, 85''x 96''
- Z-1347-2015 — (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Microtek Medical, Inc.
- K110358 — VENODYNE V810
- K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
- K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA
- K060200 — MICROTEK MEDICAL WARMING DRAPE
- K050322 — MICROTEK EQUIPMENT DRAPES
- K022903 — CHILLBUSTER
- K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
- K011318 — VENODYNE DVT ADVANTAGE PLUS
- K001802 — VENODYNE DVT ADVANTAGE MODEL 610
- K950906 — LESINSKI SURGICAL EAR DRESSING
- K925610 — FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
- K874535 — MICROTEK MINI-MAX DRILL SYSTEM
- K862496 — MICROTEK INTRANASAL SPLINT
- K862497 — MICROTEK SEPTAL BUTTON
- K860460 — MICROTEK STAINLESS STEEL PISTON
- K844061 — MICROTEK IRRIGATION SYSTEM
- K833608 — GOLD ALLIGATOR FORCEPS
- K833601 — ANTRUM & ATTIC MIRROR
- K833602 — ROLLER KNIFE-TRANSVERSE -SAGITTAL
- K833603 — SCISSORS SHEA BELLUCC
- K833604 — ADJUSTABLE FORK RETRACTOR
- K833605 — CUPPED FORCEPS
- K833606 — IMPLANT MEASURING GAUGE
- K833607 — MCGEE FORCEPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.