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

PrecisionTAVI (v1.1)

Dasi Simulations

Extended Reservoir; MiniMed Reservoir

Medtronic Minimed

UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE

United Medical Resources, LLC

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)

Becton, Dickinson and Company

MatriDerm pluS+ Bi-Layer

Medskin Solutions Dr. Suwelack AG

Revolve Surgical System

Revolve Surgical, Inc.

Vital Signs Monitor

Beijing Choice Electronic Technology Co., Ltd.

CHIRAVAC Blood Collection Needles

Chirana T. Injecta

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Tornier, Inc.

White Endoseal MTA

Maruchi

ELEC-LED

Micro-Nx Co., Ltd.

SB Knife Jr2 (MD-47702 and MD-47702L)

Sb-Kawasumi Laboratories, Inc.

FERTI-LILY Conception Cup

Rosesta Medical BV

Trinias

Shimadzu Corporation

Spectricept Skin and Wound Cleanser

Spectrum Antimicrobials, Inc.

Medline Safety Insulin and TB Syringes

Medline Industries, LP

BLUE 400; BLUE 400 S

Carl Zeiss Meditec, AG

ACUSON Sequoia Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc.

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

Huizhou Tianchang Industrial Co., Ltd.

Cohitech Reusable Tampon Applicator

Cotton High Tech S.L.

BTL-99-OC

BTL Industries, Inc.

Disposable Vinyl Examination Gloves

Viet Phu Trade and Import Export Co., Ltd.

Fusion FibFix Nail

Fusion Orthopedics USA, LLC

Cios Alpha; Cios Flow

Siemens Medical Solutions USA, Inc.

Ziehm Vision RFD

Ziehm Imaging GmbH

MTONE EVO (MTONE EVO)

M&T S.R.L.

Surgical Face Mask

Shanghai Yunqing Industrial Co., Ltd.

Multi-Unit DAS System

Talladium España, SL

TMINI Miniature Robotic System

THINK Surgical, Inc.

Mindray SV600 Ventilator, Mindray SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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