Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78721–78744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 11, 2001
CLEARFIL PHOTO CORE
K012705 · EBF
Kuraray Medical, Inc.
Dental · 28d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 614d
Cleared Sep 10, 2001
PALOMAR DERMALUX PULSED LIGHT SYSTEM
K010618 · GEX
Palomar
General & Plastic Surgery · 193d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR...
K011044 · LYY
Shen Wei (Usa), Inc.
General Hospital · 158d
Cleared Sep 10, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 90d
Cleared Sep 10, 2001
PRESSURE ACTIVATED CHECK VALVE
K011888 · FPA
Churchill Medical Systems, Inc.
General Hospital · 84d