Panels › General Hospital › Product code FMQ · Class 1
Restraint, Protective
Regulation 880.6760
0510(k)s in 12 months (134 all time)
0recalls in 12 months (33 all time)
25recalls that name a 510(k)
Top companies in FMQ
| Company | 510(k)s | Recalls |
|---|---|---|
| J. T. Posey Co. | 9 | 25 |
| Deroyal Industries, Inc. | 15 | 3 |
| Heelbo, Inc. | 14 | 0 |
| Skil-Care Corp. | 12 | 0 |
| Tecnol Medical Products, Inc. | 9 | 0 |
| Morrison Medical Products | 8 | 0 |
| Medical Restraints, Inc. | 7 | 0 |
| Medline Industries, Inc. | 5 | 0 |
| Fla Orthopedics, Inc. | 4 | 0 |
| Hollister, Inc. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 1996 | K963411 | POSEY LAPTOP TRAYS J. T. Posey Co. | FMQ |
| Nov 15, 1996 | K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) Contour Fabricators, Inc. | FMQ |
| Nov 14, 1996 | K963491 | STUCKEY STRAP-3 FINGER RESTRAINTS Stuckey Ent., Inc. | FMQ |
| Nov 14, 1996 | K963478 | SLEEVED/SLEEVELESS VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963473 | REUSABLE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963472 | PEDIATRIC VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963471 | SUPER SECURITY RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963470 | CRISS-CROSS VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963469 | MITTENS Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963413 | MULTIPLE LIMB HOLDERS J. T. Posey Co. | FMQ |
| Nov 14, 1996 | K963409 | POSEY HUGGER J. T. Posey Co. | FMQ |
| Nov 12, 1996 | K963492 | PROTECTIVE RESTRAINT Smith and Nephew Donjoy, Inc. | FMQ |
| Nov 12, 1996 | K963490 | PROTECTIVE RESTRAINT - BELTS Smith and Nephew Donjoy, Inc. | FMQ |
| Nov 12, 1996 | K963489 | WHEEL CHAIR ACCESSORY Smith and Nephew Donjoy, Inc. | FMQ |
| Nov 12, 1996 | K963477 | PEDIATRIC MITTENS Deroyal Industries, Inc. | FMQ |
| Nov 12, 1996 | K963464 | RESTRAINT NET Deroyal Industries, Inc. | FMQ |
| Nov 8, 1996 | K963387 | DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP Morrison Medical Products | FMQ |
| Nov 8, 1996 | K963374 | TORSO/WAIST RESTRAINT Morrison Medical Products | FMQ |
| Nov 8, 1996 | K963370 | CINCH STRAP WITH BUCKLE Morrison Medical Products | FMQ |
| Nov 7, 1996 | K963372 | HEELBO ER WRIST RESTRAINT Heelbo, Inc. | FMQ |
| Nov 7, 1996 | K963371 | BEST STRAP RESTRAINT Morrison Medical Products | FMQ |
| Nov 6, 1996 | K963494 | MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP Morrison Medical Products | FMQ |
| Nov 6, 1996 | K963435 | ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE Zimmer Patient Care Division | FMQ |
| Nov 6, 1996 | K963431 | POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER Zimmer, Inc. | FMQ |
| Nov 6, 1996 | K963416 | ANKLE RESTRAINT SYSTEM Morrison Medical Products | FMQ |
| Nov 6, 1996 | K963399 | MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS Morrison Medical Products | FMQ |
| Nov 6, 1996 | K963138 | SPIDER STRAP Bdm Medical, Inc. | FMQ |
| Nov 4, 1996 | K963060 | HEELBO SECURITY BELT Heelbo, Inc. | FMQ |
| Nov 1, 1996 | K963199 | HEELBO PELVIC RESTRAINT Hollister, Inc. | FMQ |
| Nov 1, 1996 | K963099 | HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET Heelbo, Inc. | FMQ |
| Oct 31, 1996 | K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS Alimed, Inc. | FMQ |
| Oct 31, 1996 | K963419 | MORRISON MEDICAL WRIST RESTRAINT Morrison Medical Products | FMQ |
| Oct 31, 1996 | K963393 | MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT Depuy, Inc. | FMQ |
| Oct 31, 1996 | K963041 | HEELBO LIFE JACKET WITH CROTCH SUPPORT Heelbo, Inc. | FMQ |
| Oct 29, 1996 | K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) Alimed, Inc. | FMQ |
| Oct 29, 1996 | K963504 | MEDLINE OPEN END FINGER CONTROL MITT Medline | FMQ |
| Oct 29, 1996 | K963378 | MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER Medline Industries, Inc. | FMQ |
| Oct 28, 1996 | K963526 | STRAP WEDGE Alimed, Inc. | FMQ |
| Oct 24, 1996 | K962964 | HEELBO JOHNNY GRAIT BELT SECURITY BELT Hollister, Inc. | FMQ |
| Oct 24, 1996 | K962963 | CHECKMATE ANKLE RESTRAINT SYSTEM Hollister, Inc. | FMQ |
| Oct 18, 1996 | K963569 | WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH Medline Industries, Inc. | FMQ |
| Oct 18, 1996 | K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS Skil-Care Corp. | FMQ |
| Oct 18, 1996 | K963452 | MEDLINE ZIPPER SLEEVED VEST Medline | FMQ |
| Oct 18, 1996 | K963404 | MEDLINE PELVIC HOLDER Medline Industries, Inc. | FMQ |
| Oct 18, 1996 | K963362 | MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT Medline Industries, Inc. | FMQ |
| Oct 18, 1996 | K963360 | MEDLINE BODY HOLDER Medline Industries, Inc. | FMQ |
| Oct 18, 1996 | K962839 | HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP Heelbo, Inc. | FMQ |
| Oct 18, 1996 | K962834 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP Heelbo, Inc. | FMQ |
| Oct 18, 1996 | K962832 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP Heelbo, Inc. | FMQ |
| Oct 18, 1996 | K962831 | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE Heelbo, Inc. | FMQ |
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