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
81553–81576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 30, 2000
NEUROVASCULAR ARRAY COIL
K001946 · MOS
Ge Medical Systems, Inc.
Radiology · 65d
Cleared Aug 30, 2000
JBC OPAQUE AND GLITTER
K002048 · EBI
J.B.C and Co.
Dental · 65d
Cleared Aug 30, 2000
TOTAL PSA MICROTITER ELISA
K002121 · LTJ
Oncogene Science, Inc.
Immunology · 48d
Cleared Aug 30, 2000
FORAMATRON V, MODEL D680
K002195 · LQY
Parkell, Inc.
Dental · 41d
Cleared Aug 30, 2000
PROTON VISION 7.0
K002312 · MUJ
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Aug 30, 2000
COMPLEXED PSA MICROTITER ELISA
K002313 · LTJ
Oncogene Science, Inc.
Immunology · 30d
Cleared Aug 30, 2000
PURILENS SALINE SOLUTION
K002319 · LPN
Purilens, Inc.
Ophthalmic · 30d
Cleared Aug 30, 2000
MODIFICATION OF ACL ADVANCE
K002400 · JPA
Instrumentation Laboratory CO
Hematology · 26d