FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139417–139440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1987
MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER
K871719 · DXN
A&D Engineering, Inc.
Cardiovascular · 32d
Cleared Jun 05, 1987
MASTER MEDICAL DEVICE IS I.V. STAT 2
K871753 · FPA
The Master Medical Corp.
General Hospital · 31d
Cleared Jun 05, 1987
LIDO ACTIVE
K871793 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 29d
Cleared Jun 05, 1987
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
K871808 · ELL
Degussa Dental, Inc.
Dental · 28d
Cleared Jun 05, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · DXY
Telectronics, Inc.
Cardiovascular · 23d
Cleared Jun 05, 1987
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
K871891 · HSZ
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 21d
Cleared Jun 05, 1987
IMPRESSION SYRINGE
K871937 · EID
Dentsply Intl.
Dental · 18d
Cleared Jun 05, 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
K871975 · CEK
Simmler, Inc.
Chemistry · 14d
Cleared Jun 05, 1987
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
K871976 · CFR
Simmler, Inc.
Chemistry · 14d
Cleared Jun 05, 1987
D-23 DENTURE ADHESIVE
K871980 · KOJ
Solar Dental Co., Inc.
Dental · 14d
Cleared Jun 04, 1987
ADENOLEX (R) LATEX AGGLUTINATION TEST
K864645 · GOD
Orion Diagnostica, Inc.
Microbiology · 191d
Cleared Jun 04, 1987
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
K870814 · GQL
Microscan Div. Baxter Healthcare Corp.
Microbiology · 93d
Cleared Jun 04, 1987
KODNER ANAL PERIONEAL RETRACTOR
K870897 · FFO
Sur-Med Instruments, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 04, 1987
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
K870991 · FRN
Imed Corp.
General Hospital · 85d
Cleared Jun 04, 1987
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
K870992 · FRN
Imed Corp.
General Hospital · 85d
Cleared Jun 04, 1987
ENTROSET-SW
K871003 · KNT
White River (Tm)
Gastroenterology & Urology · 84d
Cleared Jun 04, 1987
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · DZE
Depuy, Inc.
Dental · 69d
Cleared Jun 04, 1987
FIRST AID KIT, VARIOUS SIZES
K871376 · LRR
Fraass Survival Systems, Inc.
General & Plastic Surgery · 58d
Cleared Jun 04, 1987
PROSTHETIC - FEMORAL HIP COMPONENT
K871462 · JDI
Louis A. Serafin, Jr., M.D.
Orthopedic · 51d
Cleared Jun 04, 1987
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
K871780 · CIT
Biochemical Trade, Inc.
Chemistry · 29d
Cleared Jun 03, 1987
BILIRUBIN TESTER
K870095 · CIG
Wako Chemicals USA, Inc.
Chemistry · 145d
Cleared Jun 03, 1987
FREEDOM SET II WITH TRIFLEX VALVE
K870626 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 03, 1987
HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS
K870979 · KPO
Inventory Supply Corp.
Gastroenterology & Urology · 85d
Cleared Jun 03, 1987
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
K871235 · JHI
Hybritech, Inc.
Chemistry · 68d