Panels › General, Plastic Surgery › Product code LYU · Class 1
Accessory, Surgical Apparel
Regulation 878.4040
0510(k)s in 12 months (56 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in LYU
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 6 |
| Medical Armor Corp. | 5 | 0 |
| Sloan Corp. | 3 | 0 |
| Wells Lamont Corp. | 3 | 0 |
| Aor-Sullivan | 2 | 0 |
| Depuy-Raynham | 2 | 0 |
| Derekduck Industries Corp. | 2 | 0 |
| Instrument Makar, Inc. | 2 | 0 |
| Lovell-Schenck, Inc. | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2001 | K011755 | STRYKER T4 HYTREL (R) TOGAS Stryker Corp. | LYU |
| Aug 27, 1997 | K965237 | NURSES BOUFFANT CAP Copioumed Intl., Inc. | LYU |
| Jul 10, 1997 | K970988 | FAR-EAST BOUFFANT CAPS Far East Science & Technology Development Co., Ltd., CN | LYU |
| Feb 25, 1997 | K964364 | DISPOSABLE APRON Instrument Makar, Inc. | LYU |
| Aug 9, 1996 | K961791 | DEPUY DISPOSABLE FILTER/HOOD Depuy, Inc. | LYU |
| Jul 25, 1996 | K961454 | AMMI MAGNI-GUARD American Medical Mfg., Inc. | LYU |
| Mar 19, 1996 | K945302 | SLOAN STA-DRI PANT PROTECTOR Sloan Corp. | LYU |
| Dec 28, 1995 | K954314 | ULTRAFIT LINERS Stahmer Weston Scientific | LYU |
| Oct 16, 1995 | K953089 | I-SPOUSE Products For Medicine | LYU |
| Aug 24, 1995 | K952303 | SPLASH ASSIST Innovative Outsourcing Solutions | LYU |
| Aug 7, 1995 | K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS Thantex Specialties, Inc. | LYU |
| Jul 31, 1995 | K944276 | SLOAN STA-DRI BOOTLEG LEGGING Sloan Corp. | LYU |
| Jul 31, 1995 | K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT Sloan Corp. | LYU |
| Jun 28, 1995 | K946003 | INTEC FULL FACE SHIELD Intec Industries, Inc. | LYU |
| Jun 8, 1995 | K951420 | INCASE EXTENSIBLE BAG--NON-STERILE Alpha Surgical, Inc. | LYU |
| Apr 10, 1995 | K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER Wells Lamont Corp. | LYU |
| Feb 28, 1995 | K945098 | OP-D-OP II Op-D-Op Visor Shields, Inc. | LYU |
| Feb 23, 1995 | K942828 | MAKAR FULL AND HALF FACE SHIELD Instrument Makar, Inc. | LYU |
| Nov 28, 1994 | K943809 | MONOGARD FACE SHIELD White Knight Healthcare | LYU |
| Sep 26, 1994 | K940228 | BOUFFANT CAP Derekduck Industries Corp., CN | LYU |
| Sep 26, 1994 | K940226 | SHOE COVER Derekduck Industries Corp., CN | LYU |
| Sep 6, 1994 | K940723 | BODY BOOT Mark-Clark | LYU |
| Jul 19, 1994 | K941932 | SPLASH MASK Incon Diversified Industries, Inc. | LYU |
| Jul 8, 1994 | K942022 | FACE-IT SHIELD Onyx Medical Corp. | LYU |
| Jun 24, 1994 | K932953 | DERMAL GLOVES George Glove Company, Inc. | LYU |
| May 12, 1994 | K940274 | NYLON LINER GLOVES Wells Lamont Corp. | LYU |
| Apr 20, 1994 | K935158 | KACEY DISPOSABLE GLOVE LINER K & C Medical, Inc. | LYU |
| Apr 13, 1994 | K931042 | MOORE SECURE CAP Kerma Medical Products, Inc. | LYU |
| Apr 6, 1994 | K935723 | SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) Cabot Safety Corp. | LYU |
| Mar 9, 1994 | K934842 | TECNOL SPLASHGUARD Tecnol Medical Products, Inc. | LYU |
| Feb 14, 1994 | K931094 | PROCEL(TM) DERMALINER GLOVE W. L. Gore & Associates, Inc. | LYU |
| Feb 1, 1994 | K935779 | AGAFAR FACE SHIELD Infection Control Products, Inc. | LYU |
| Jan 21, 1994 | K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD Louis M. Gerson Co., Inc. | LYU |
| Aug 18, 1993 | K926438 | ACTION MEDTEK FACE SHIELD Action Eyewear Corp. | LYU |
| Jul 23, 1993 | K925290 | CATALOG NUMBER 111 (FACESHIELD) Ansley Medical Products, Inc. | LYU |
| Jul 9, 1993 | K925628 | ULTRATUFF CUT RESISTANT GLOVE LINER Baxter Healthcare Corp | LYU |
| Jun 15, 1993 | K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS Wells Lamont Corp. | LYU |
| May 7, 1993 | K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE Medical Armor Corp. | LYU |
| Oct 15, 1992 | K915415 | GUARDALL SHIELD Anago, Inc. | LYU |
| Feb 3, 1992 | K915056 | FINGGUARD Allied Signal, Inc. | LYU |
| Dec 2, 1991 | K914077 | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS Depuy-Raynham | LYU |
| Oct 8, 1991 | K912737 | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV Medical Armor Corp. | LYU |
| Oct 4, 1991 | K912457 | MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO Medical Armor Corp. | LYU |
| Jun 27, 1991 | K910890 | NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER Lovell-Schenck, Inc. | LYU |
| Jun 7, 1991 | K911742 | OP-D-OP VISOR SHIELDS Op-D-Op, Inc. | LYU |
| Jan 8, 1991 | K904903 | PARADERM(TM) SURGEON'S GLOVE ACCESSORY Lovell-Schenck, Inc. | LYU |
| Sep 7, 1990 | K900425 | SURGICAL COTTON GLOVES Allo Pro Corp. | LYU |
| Jul 27, 1990 | K902633 | CUT RESISTANT GLOVE LINER Biomet, Inc. | LYU |
| Jul 10, 1990 | K901221 | PHYSICIAN BARRIER GLOVE, SURGICAL Dynamic Marketing Ent. | LYU |
| May 16, 1990 | K902016 | MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE Aor-Sullivan | LYU |
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