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Panels › Physical Medicine › Product code IMD · Class 1

Pack, Hot Or Cold, Disposable

Regulation 890.5710

0510(k)s in 12 months (82 all time)
0recalls in 12 months (26 all time)
12recalls that name a 510(k)
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Top companies in IMD

DateFirm and productCodeLinked 510(k)
Sep 19, 2024Safeguard US Operating LLC
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as f
Open, Classified
IMDNone listed
Sep 19, 2024Safeguard US Operating LLC
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Open, Classified
IMDNone listed
Sep 19, 2024Safeguard US Operating LLC
HAWK Warming Grid, Item Number: 59-300
Open, Classified
IMDNone listed
Jan 19, 2022Philips North America Llc
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Open, Classified
IMDK936084
Jan 19, 2022Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Open, Classified
IMDK936084
Jan 19, 2022Philips North America Llc
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Open, Classified
IMDK936084
Jan 18, 2022Philips North America Llc
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Open, Classified
IMDK936084
Jul 8, 2019CooperSurgical, Inc.
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two ho
Terminated
IMDK934631
Apr 26, 2019PF Consumer Healthcare 1 LLC
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for th
Terminated
IMDNone listed
Apr 26, 2019PF Consumer Healthcare 1 LLC
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular a
Terminated
IMDNone listed
Oct 2, 2018Pfizer Inc.
Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular
Terminated
IMDNone listed
Oct 2, 2018Pfizer Inc.
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
Terminated
IMDNone listed
Oct 2, 2018Pfizer Inc.
Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with ove
Terminated
IMDNone listed
Apr 4, 2016Philips Electronics North America Corporation
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Terminated
IMDNone listed
Apr 4, 2016Philips Electronics North America Corporation
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Terminated
IMDK936084
Dec 24, 2015Philips Electronics North America Corporation
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Terminated
IMDK936084
Apr 7, 2015CooperSurgical, Inc.
CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport o
Terminated
IMDK934631
Mar 19, 2015CooperSurgical, Inc.
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant
Terminated
IMDK912715
Mar 19, 2015CooperSurgical, Inc.
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat t
Terminated
IMDK912715
Mar 19, 2015CooperSurgical, Inc.
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample
Terminated
IMDK912715
Mar 19, 2015CooperSurgical, Inc.
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
Terminated
IMDK912715
Dec 16, 2010Pfizer Global
ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
Terminated
IMDNone listed
Sep 26, 2008Becton Dickinson & Company
Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches Distributed by: BD Medical, Franklin
Terminated
IMDNone listed
Mar 8, 2008Chattem Inc
Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5c
Terminated
IMDNone listed
Mar 8, 2008Chattem Inc
Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed
Terminated
IMDNone listed
Mar 8, 2008Chattem Inc
Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem
Terminated
IMDNone listed

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