FDA 510(k) medical devices

FDA 510(k) incl. De Novo Clear all

Introducer, Percutaneous Ref K812143

Willson,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
Jms Av Fistula Needles Ref K911199

Jms Co., Ltd.,Japan

Active Regimes: 510(k) Registry: 510(k) Class:II
Multi-Drug Control Set Ref K951135

Microgenics Corporation,United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Jms Av Fistula Needle Ref K970962

Jms Co., Ltd.,Japan

Active Regimes: 510(k) Registry: 510(k) Class:II
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 Ref K182979

Philips Medizin Systeme Boeblingen GmbH,FDA registration: Germany

Active Regimes: 510(k) Registry: 510(k) Class:II
ST AIA-PACK hsE2 Calibrator Set Ref K160113

Tosoh Bioscience, Inc.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
T4 Diagnostic Kit Ref K820251

Diagnostic Reagents, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Expedium Spine System, Viper System, Viper 2 System Ref K111136

Depuy Spine, Inc.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
Patient Examination Gloves (Vinyl) Ref K892607

Disposable Products Co.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow Ref K170575

Ever Global (Vietnam) Enterprise Corporation,Vietnam(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:I
Angiosculpt Pta Scoring Balloon Catheter Ref K082059

Angioscore, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Disposable Endoscopic Cutter Stapler and Cartridge Ref K211197

Changzhou Waston Medical Appliance Co., Ltd,China

Active Regimes: 510(k) Registry: 510(k) Class:II
ST80I Stress Test System Ref K121638

Philips Health Care,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
Youlaser PRIME Ref K241092

Quanta System SpA

Active Regimes: 510(k) Registry: 510(k) Class:II
Campylobacter Blood-Free Selective Agar Base Ref K850658

Oxoid U.S.A., Inc.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid Ref K252549

Kossan International Sdn Bhd,Malaysia

Active Regimes: 510(k) Registry: 510(k) Class:I
Gauze Sponge, X-Ray Detectable Ref K882708 Open recall

Bioseal, Inc.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Beckman Hdl Cholesterol Reagent Ref K934045

Beckman Instruments, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:I
Ea 65 Ref K812086

Surgipath,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
Logiq E10 Ref K211488

GE Healthcare,United States

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA 510(k) medical devices

Category (EMDN)

Introducer, Percutaneous Ref K812143

Jms Av Fistula Needles Ref K911199

Multi-Drug Control Set Ref K951135

Jms Av Fistula Needle Ref K970962

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 Ref K182979

ST AIA-PACK hsE2 Calibrator Set Ref K160113

T4 Diagnostic Kit Ref K820251

Expedium Spine System, Viper System, Viper 2 System Ref K111136

Patient Examination Gloves (Vinyl) Ref K892607

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow Ref K170575

Angiosculpt Pta Scoring Balloon Catheter Ref K082059

Disposable Endoscopic Cutter Stapler and Cartridge Ref K211197

ST80I Stress Test System Ref K121638

Youlaser PRIME Ref K241092

Campylobacter Blood-Free Selective Agar Base Ref K850658

Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid Ref K252549

Gauze Sponge, X-Ray Detectable Ref K882708 Open recall

Beckman Hdl Cholesterol Reagent Ref K934045

Ea 65 Ref K812086

Logiq E10 Ref K211488