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
75121–75144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2002
CALSCOR SOFTWARE
K021913 · LLZ
3D Med Co., Ltd.
Radiology · 87d
Cleared Sep 06, 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · JEY
Synthes (Usa)
Dental · 86d
Cleared Sep 06, 2002
ENDOSCOPIC FIBEROPTIC CABLE
K021931 · HBI
Gulf Medical Fiberoptics
General & Plastic Surgery · 86d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
THERMIQUE
K022097 · EAT
Parkell, Inc.
Dental · 71d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Abbott Laboratories
Chemistry · 65d
Cleared Sep 06, 2002
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
K022229 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Sep 06, 2002
G-1 VERSION 3, MODEL 10048
K022244 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
G-FERT, MODEL 10033
K022245 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
G-SPERM, MODEL 10032
K022247 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d
Cleared Sep 06, 2002
CEREC VITABLOCKS MK2
K022408 · EIH
B.B.'S Prophy Shop
Dental · 44d
Cleared Sep 06, 2002
X-SCRIBE II
K022618 · DPS
Mortara Instrument, Inc.
Cardiovascular · 30d
Cleared Sep 06, 2002
POWDER FREE NITRILE EXAMINATION GLOVES
K022619 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Sep 06, 2002
KUSKE BREAST APPLICATOR SET, MODEL 189.006
K022635 · JAQ
Nucletron Corporation
Radiology · 29d
Cleared Sep 06, 2002
COOK-SWARTZ DOPPLER FLOW PROBE
K022649 · ITX
Cook Vascular, Inc.
Radiology · 28d
Cleared Sep 06, 2002
LR DICOM CONTROLLER
K022658 · LMC
Agfa Corp.
Radiology · 28d
Cleared Sep 06, 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · MOS
GE Medical Systems
Radiology · 25d
Cleared Sep 06, 2002
CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
K022720 · MOS
Mri Devices Corp.
Radiology · 22d
Cleared Sep 06, 2002
STAYFUSE GT-IP
K022726 · HWC
Pioneer Surgical Technology
Orthopedic · 21d
Cleared Sep 06, 2002
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE...
K022735 · HCG
MicroVention, Inc.
Neurology · 18d
Cleared Sep 06, 2002
VIATRONIX V3D EXPLORER
K022789 · LLZ
Viatronix, Inc.
Radiology · 15d
Cleared Sep 06, 2002
CERCON CERAM S PORCELAIN
K022796 · EIH
Dentsply Intl.
Dental · 14d
Cleared Sep 06, 2002
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K022858 · IYN
Novasonics, Inc.
Radiology · 9d
Cleared Sep 06, 2002
MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING...
K022890 · JEY
Bioplate, Inc.
Dental · 7d