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

Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cycl

Central Medicare Sdn Bhd

Fine Osteotomy™

Bodycad Laboratories, Inc.

Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

Jiujiang Taixin Technology Co., Ltd.

AION TempShield™

Aion Biosystems, Inc.

Partial Flex

Clemde SA DE CV

ICS Dizcovery (1091)

Natus Medical Denmark Aps

swiftPro System

Emblation , Ltd.

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

Lina Medical Aps

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Quanta Dialysis Technologies, Ltd.

Injectable Root Canal Bioceramic Sealer (i-MTA SP)

Longly Biotechnology (Wuhan) Co., Ltd.

Renova RP Centesis Pump

Gi Supply, Inc.

ArtiSential Laparoscopic Instruments-Electrodes

Livsmed, Inc.

“Socko” Vimax Spinal Fixation System

Socko Medical Co., Ltd.

VITROS AFP

Ortho Clinical Diagnostics

Serranator PTA Serration Balloon Catheter

Cagent Vascular, LLC

OTOPLAN

Cascination AG

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

Depuy Ireland UC

Materialise TKA Guide System

Materialise NV

Somfit D

Compumedics Limited

UltraPrint-Dental Denture UV

Guangzhou Heygears IMC., Inc.

DESS Dental Smart Solutions

Terrats Medical SL

Terragene® Bionova® BT20 Biological Indicator

Terragene

K-Bond Universal

Spident Co., Ltd.

Soniquence Reusable Neutral Plate

Soniquence, LLC

Insignia Hip Stem

Stryker Orthopaedics

ANT-X System

Ndr Medical Technology Pte. , Ltd.

Alveoair Digital Spirometer

Roundworks Technologies Private Limited

Distal Elbow Plating System

Skeletal Dynamics, Inc.

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Gimbo Medical Technology Shenzhen Co., Ltd.

Procedure Mask

Little Rapids Corporation

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