RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

BrainSpec Core™ Software

Brainspec, Inc.

UpDoc

Updoc, Inc.

Viz RV/LV

Viz. Ai, Inc.

Clear Miracle

Ods Co., Ltd.

Tempo Tampon

Dong-A Pharmaceutical Co., Ltd.

SCARLET® AC-Ti

Spineart SA

Fibresolve (with PCCP)

Imvaria, Inc.

Medline UNITE® Medial Malleolus Peg Plate System

Medline Industries, LP

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

Shenzhen Qianyu Technology Co., Ltd.

Dental Implants and Abutments

Ditron Dental, Ltd.

Gemini Medical Cage System

ZheJiang Decans Medical Devices Co., Ltd.

Trigon Trigon HA Stand-Alone Wedge Fixation System

Nvision Biomedical Technologies

UltraGuideCTR® image guided soft tissue release system

Sonex Health

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

Philips Medizin Systeme Boeblingen GmbH

HeartKey® Rhythm

B-Secur Limited

Flowflex Plus COVID-19 + Flu A/B Home Test

ACON Laboratories, Inc.

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

Concentriq Dx

Proscia, Inc.

SchurSign Tissue Marker

Surgmark GmbH

Novum IQ Syringe Pump (40800BAXUS)

Baxter Healthcare Corporation

Biotres

Biotricity

KIDS Arterial Filters

Sorin Group Italia S.R.L.

MFG-05

Zimmer Medizinsysteme GmbH

Implanova

Dental Evolutions, Inc.

Disposable Surgical Mask

Heilongjiang Yinjia Medical Equipment Co., Ltd.

TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate),

TriMed, Inc.

Skin Care Beauty Mask (Model: MJ-06)

Shenzhen Kaiyan Medical CO , Ltd.

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model

STERIS Corporation

PRORAD X-Ray Flat Panel Detector with DROC

Prognosys Medical Systems Private Limited

Infinity CentralStation Wide

Draeger Medical Systems, Inc.

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