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
82153–82176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · JDQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Aug 31, 2000
3D ACTIVETRAC
K001712 · ITH
The Saunders Group
Physical Medicine · 87d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760 · LXT
Biomet, Inc.
Orthopedic · 83d
Cleared Aug 31, 2000
VASOTRAX
K001898 · DXN
Medwave, Inc.
Cardiovascular · 70d
Cleared Aug 31, 2000
OLEEVA FOAM
K002109 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 50d
Cleared Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
K002149 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Aug 31, 2000
RD-2104
K002222 · EJT
J.F. Jelenko & Co., Inc.
Dental · 38d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · DRF
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared Aug 31, 2000
M2A 28MM RINGLOC LINER
K002379 · KWA
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 31, 2000
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
K002402 · HRX
Mitek Products
Orthopedic · 24d
Cleared Aug 31, 2000
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM
K002422 · GEI
Mitek Products
General & Plastic Surgery · 23d
Cleared Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS...
K002453 · LGD
Beckman Coulter, Inc.
Microbiology · 21d
Cleared Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
K002460 · JJY
Bio-Rad
Chemistry · 21d
Cleared Aug 31, 2000
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE...
K002528 · JBP
Sienco, Inc.
Hematology · 15d
Cleared Aug 31, 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · KFM
Jostra Medizintechnik AG
Cardiovascular · 457d
Cleared Aug 31, 2000
PARALLAX CRANIOSET
K994022 · GXP
Parallax Medical, Inc.
Neurology · 279d
Cleared Aug 31, 2000
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041 · KWI
Tornier, Inc.
Orthopedic · 276d
Cleared Aug 30, 2000
SPECTRUM SILICONE FOLEY CATHETER
K000251 · MJC
Cook Urological, Inc.
Gastroenterology & Urology · 216d
Cleared Aug 30, 2000
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
K001052 · IYE
Med-Tec,Inc.
Radiology · 149d
Cleared Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
K001127 · MOB
The Binding Site, Ltd.
Immunology · 149d
Cleared Aug 30, 2000
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
K001300 · DWL
Confection Medicale D.R., Inc.
General Hospital · 128d
Cleared Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Aug 30, 2000
SLIDESCAN
K001420 · JOY
Applied Imaging Corp.
Hematology · 117d
Cleared Aug 30, 2000
UTERINE TENACLUM HOOK
K001818 · HDC
Towne Brothers (Pvt.), Ltd.
Obstetrics & Gynecology · 76d