29 results
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17ms
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Sources: EU EUDAMED, US FDA
inLight Medical LED Pads used with Polychromatic light technology system
FDA Recall
Terminated
·Inlightened Partners LLC·Product code ILY·June 4, 2019
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
FDA Recall
Terminated
·Cutera Inc·Product code ILY·May 8, 2010
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
FDA Recall
Terminated
·Pivotal Health Solutions·Product code ILY·December 17, 2014
Foot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated foot massager intended for over the counter use.
FDA Recall
Terminated
·Suarez Corporation Industries·Product code ILY·August 7, 2006
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.
FDA Recall
Terminated
·Product code ILY·March 30, 2016
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
FDA Recall
Terminated
·Biocare Systems Inc.·Product code ILY·June 14, 2006
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico·Product code ILI·April 12, 2021
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code ILI·October 31, 2016
1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·May 2, 2018
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·March 19, 2004
Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
FDA Recall
Terminated
·Cepheid·Product code NJR·April 1, 2011
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JQP·September 17, 2018
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
FDA Recall
Terminated
·Optovue, Inc.·Product code HLI·July 27, 2017
Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
FDA Recall
Terminated
·Keeler Instruments Inc·Product code HLI·January 8, 2008