Company ยท US
Microtek Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2025. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
25recalls (0 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | 10 |
| FYA | Gown, Surgical | 6 |
| KPE | Container, I.V. | 5 |
| JOW | Sleeve, Limb, Compressible | 3 |
| KAE | Forceps, Ent | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 |
| PUI | Drape, Surgical, Exempt | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 |
| DWJ | System, Thermal Regulating | 1 |
| DZI | Drill, Bone, Powered | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| EPP | Splint, Nasal | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 |
| FWP | Prosthesis, Chin, Internal | 1 |
| GBX | Catheter, Irrigation | 1 |
| JYJ | Gauge, Measuring | 1 |
| JYO | Knife, Ear | 1 |
| JZB | Scissors, Ear | 1 |
| KAI | Mirror, Ent | 1 |
| KAL | Retractor, Ent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2025 | K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte Microtek Medical, LLC | LHI |
| May 5, 2011 | K110358 | VENODYNE V810 Microtek Medical, Inc. | JOW |
| Feb 23, 2011 | K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK Microtek Medical, Inc. | FYA |
| Jan 25, 2007 | K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA Microtek Medical, Inc. | FYA |
| May 31, 2006 | K060200 | MICROTEK MEDICAL WARMING DRAPE Microtek Medical, Inc. | KKX |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES Microtek Medical, Inc. | KKX |
| Nov 27, 2002 | K022903 | CHILLBUSTER Microtek Medical, Inc. | DWJ |
| May 16, 2002 | K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA Microtek Medical, Inc. | MUI |
| Oct 25, 2001 | K011318 | VENODYNE DVT ADVANTAGE PLUS Microtek Medical, Inc. | JOW |
| Jan 9, 2001 | K001802 | VENODYNE DVT ADVANTAGE MODEL 610 Microtek Medical, Inc. | JOW |
| Jun 22, 1995 | K950906 | LESINSKI SURGICAL EAR DRESSING Microtek Medical, Inc. | EFQ |
| Nov 18, 1994 | K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN Microtek Medical, Inc. | FWP |
| Nov 23, 1987 | K874535 | MICROTEK MINI-MAX DRILL SYSTEM Microtek Medical, Inc. | DZI |
| Jul 14, 1986 | K862497 | MICROTEK SEPTAL BUTTON Microtek Medical, Inc. | LFB |
| Jul 14, 1986 | K862496 | MICROTEK INTRANASAL SPLINT Microtek Medical, Inc. | EPP |
| Jul 11, 1986 | K860460 | MICROTEK STAINLESS STEEL PISTON Microtek Medical, Inc. | ETB |
| May 21, 1985 | K844061 | MICROTEK IRRIGATION SYSTEM Microtek Medical, Inc. | GBX |
| Jan 11, 1984 | K833608 | GOLD ALLIGATOR FORCEPS Microtek Medical, Inc. | KAE |
| Jan 3, 1984 | K833607 | MCGEE FORCEPS Microtek Medical, Inc. | KAE |
| Jan 3, 1984 | K833606 | IMPLANT MEASURING GAUGE Microtek Medical, Inc. | JYJ |
| Jan 3, 1984 | K833605 | CUPPED FORCEPS Microtek Medical, Inc. | KAE |
| Jan 3, 1984 | K833604 | ADJUSTABLE FORK RETRACTOR Microtek Medical, Inc. | KAL |
| Jan 3, 1984 | K833603 | SCISSORS SHEA BELLUCC Microtek Medical, Inc. | JZB |
| Jan 3, 1984 | K833602 | ROLLER KNIFE-TRANSVERSE -SAGITTAL Microtek Medical, Inc. | JYO |
| Jan 3, 1984 | K833601 | ANTRUM & ATTIC MIRROR Microtek Medical, Inc. | KAI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2025 | Microtek Medical, Inc. 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
T Open, Classified |
PUI | None listed |
| Aug 16, 2024 | Microtek Medical Inc. 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). Open, Classified |
KPE | K811268 |
| Aug 16, 2024 | Microtek Medical Inc. 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). Open, Classified |
KPE | K811269 |
| Aug 16, 2024 | Microtek Medical Inc. 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). Open, Classified |
KPE | K811234 |
| Aug 16, 2024 | Microtek Medical Inc. 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). Open, Classified |
KPE | K811233 |
| Aug 16, 2024 | Microtek Medical Inc. 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). Open, Classified |
KPE | K811233 |
| Jul 28, 2023 | Microtek Medical Inc. 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/Clean Open, Classified |
KME | None listed |
| Jul 28, 2023 | Microtek Medical Inc. 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, Open, Classified |
PUI | None listed |
| Apr 8, 2022 | Microtek Medical Inc. TMJ Arthroscopy Drape, 85''x 96'' Terminated |
PUI | None listed |
| Mar 27, 2015 | Microtek Medical Inc INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or pow Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc (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 evacuat Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke creat Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser su Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX
Intended use: The smoke evacuator and accessories are intended to Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc LAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the s Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating Terminated |
FYA | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating Terminated |
FYA | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment Terminated |
FYA | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical pe Terminated |
FYA | K001082 K910515 |
| Jan 5, 2011 | Microtek Medical Inc MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue b Terminated |
CAE | None listed |
| Dec 10, 2010 | Microtek Medical, Inc. Microtek Medical, Inc., Microscope Drape for Zeiss Standard
Model/Catalog Number: 70890655
Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to prot Terminated |
KKX | K050322 |
| Jul 28, 2010 | Microtek Medical Inc MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microt Terminated |
FYD | K001082 |