FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77593–77616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL...
K011918 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 84d
Cleared Sep 12, 2001
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · HQD
Polymer Technology Corp.
Ophthalmic · 83d
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Sep 12, 2001
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · KNW
Senorx, Inc.
Gastroenterology & Urology · 76d
Cleared Sep 12, 2001
ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
K012116 · FRO
Acrymed, Inc.
General & Plastic Surgery · 68d
Cleared Sep 12, 2001
GLUCOMETER DEX TEST SENSOR
K012205 · NBW
Bayer Corp.
Chemistry · 58d
Cleared Sep 12, 2001
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
K012262 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
K012266 · MRZ
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · DKB
Randox Laboratories, Ltd.
Toxicology · 51d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Sep 12, 2001
LIQUICHEK TDM CONTROL
K012741 · DIF
Bio-Rad
Chemistry · 27d
Cleared Sep 12, 2001
SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K012867 · IYN
Medison America, Inc.
Radiology · 16d
Cleared Sep 12, 2001
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
K012887 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Sep 11, 2001
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
K010303 · NGR
Artscan Medical Innovations
Orthopedic · 280d
Cleared Sep 11, 2001
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00
K010973 · JIL
Hypoguard USA, Inc.
Chemistry · 162d
Cleared Sep 11, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS...
K011045 · LYY
Shen Wei (Usa), Inc.
General Hospital · 159d
Cleared Sep 11, 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM...
K011066 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 155d
Cleared Sep 11, 2001
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011242 · MQX
Acusupply, Inc.
General Hospital · 141d
Cleared Sep 11, 2001
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
K011403 · LYC
Orthogen Corp.
Dental · 127d
Cleared Sep 11, 2001
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50...
K011407 · LYY
Sempermed USA, Inc.
General Hospital · 145d
Cleared Sep 11, 2001
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
K011848 · FFK
Circon Video
Gastroenterology & Urology · 90d
Cleared Sep 11, 2001
ELEC-MATE E
K011926 · EBW
Nakanishi, Inc.
Dental · 83d
Cleared Sep 11, 2001
CHURCHILL MEDICAL SYSTEMS STOPCOCK
K012157 · FMG
Churchill Medical Systems, Inc.
General Hospital · 62d