FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78097–78120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2001
OTO-CEM
K011338 · NEA
Ototech, Inc.
Ear, Nose, Throat · 134d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009 · JAK
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 13, 2001
AQUARIUSNET SERVER
K012086 · LLZ
Terarecon,Inc.
Radiology · 72d
Cleared Sep 13, 2001
ESTENIA
K012707 · EBF
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL REPAIR
K012729 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL PORCELAIN BOND ACTIVATOR
K012730 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174,...
K012871 · KWP
Interpore Cross Intl.
Orthopedic · 17d
Cleared Sep 12, 2001
VECTORVISION HIP
K010602 · HAW
Brainlab AG
Neurology · 196d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Synthes (Usa)
Orthopedic · 90d
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