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
93193–93216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · JAD
Victoreen, Inc.
Radiology · 223d
Cleared Jul 21, 1997
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
K970178 · KNT
Corpak, Inc.
Gastroenterology & Urology · 185d
Cleared Jul 21, 1997
FLEXART V3.5 SOFTWARE
K970573 · LNH
Toshiba America Mri, Inc.
Radiology · 157d
Cleared Jul 21, 1997
CHASE VESSEL CANNULA
K971019 · DWF
Chase Medical, Inc.
Cardiovascular · 123d
Cleared Jul 21, 1997
DINABASE (TM)
K971138 · EBI
Sultan Chemists, Inc.
Dental · 115d
Cleared Jul 21, 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · DYB
Cordis Corp.
Cardiovascular · 81d
Cleared Jul 21, 1997
ANTIBACTERIAL GUTTA PERCHA
K971641 · EKM
Dr. Howard Martin, P.A.
Dental · 80d
Cleared Jul 21, 1997
TIADAPT ABUTMENT SYSTEM
K971706 · NHA
Nobel Biocare Uas, Inc.
Dental · 74d
Cleared Jul 21, 1997
CAUTERIZATION SMOKE EVACUATOR
K971758 · GEI
Applied Medical Technologies
General & Plastic Surgery · 69d
Cleared Jul 21, 1997
MOMO DESIGN OR MOMO
K972416 · HQY
Momo U.S.A., Inc.
Ophthalmic · 24d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671 · CDQ
Pointe Scientific, Inc.,
Chemistry · 4d
Cleared Jul 18, 1997
MODIFIED PEDIKAIR
K954320 · FNM
Kinetic Concepts, Inc.
General Hospital · 680d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 463d
Cleared Jul 18, 1997
STERILE AMBULATORY RESERVOIR 60ML/100ML
K962159 · MRZ
Faulding Medical Device Co.
General Hospital · 409d
Cleared Jul 18, 1997
PULSE*SPRAY INJECTOR
K963574 · FRN
AngioDynamics, Inc.
General Hospital · 315d
Cleared Jul 18, 1997
CARDIOMAGIC 2000 SOFTWARE
K964036 · DXH
Instromedix, Inc.
Cardiovascular · 283d
Cleared Jul 18, 1997
ISOLYSER SDS SHARPS CONTAINER
K970547 · FMI
Thantex Specialties, Inc.
General Hospital · 156d
Cleared Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · GJT
Precision Biologicals, Inc.
Hematology · 107d
Cleared Jul 18, 1997
AESCULAP JET IRRIGATION SYSTEM
K971310 · GEI
Aesculap, Inc.
General & Plastic Surgery · 101d
Cleared Jul 18, 1997
3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160)
K971446 · GEI
3M Company
General & Plastic Surgery · 88d
Cleared Jul 18, 1997
DERMALASE
K971459 · GEX
Endo Technic Corp.
General & Plastic Surgery · 88d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K971478 · FWP
Allied Biomedical Corp.
General & Plastic Surgery · 86d
Cleared Jul 18, 1997
DURALASTIC ANATOMICAL MALAR IMPLANTS
K971479 · LZK
Allied Biomedical Corp.
General & Plastic Surgery · 86d