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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115969–115992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1992
DEXTROLYTE II CAPD TRNSFER SET
K920029 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 262d
Cleared Sep 21, 1992
STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500
K920526 · IOG
Stryker Medical
Physical Medicine · 230d
Cleared Sep 21, 1992
DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
K920586 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 224d
Cleared Sep 21, 1992
DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9
K920693 · FJG
National Medical Care, Medical...
Gastroenterology & Urology · 220d
Cleared Sep 21, 1992
DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP
K920697 · FJH
National Medical Care, Medical...
Gastroenterology & Urology · 220d
Cleared Sep 21, 1992
HEMODIALYSIS BLOOD TUBING SET
K920797 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 213d
Cleared Sep 21, 1992
STRATO LIFEPORT LARGE BORE INFUSION SET
K921576 · FPA
Starto Medical Corp.
General Hospital · 172d
Cleared Sep 21, 1992
MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
K921702 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 164d
Cleared Sep 21, 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833 · FMF
Ethicon, Inc.
General Hospital · 158d
Cleared Sep 21, 1992
ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES
K922266 · HSB
Howmedica Corp.
Orthopedic · 136d
Cleared Sep 21, 1992
NEXTEC FIBEROPTIC CABLES
K922462 · HBI
Nextec Corp.
General & Plastic Surgery · 118d
Cleared Sep 21, 1992
HOWMEDICA(R) HNR SYSTEM
K922503 · JDI
Howmedica Corp.
Orthopedic · 117d
Cleared Sep 21, 1992
UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35
K922549 · ITX
Aloka Co., Ltd.
Radiology · 112d
Cleared Sep 21, 1992
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K923098 · BSY
Trinity Laboratories, Inc.
Anesthesiology · 88d
Cleared Sep 21, 1992
IR-192 IMPLANT -- MODIFICATION
K923130 · KXK
Omnitron Intl., Inc.
Radiology · 88d
Cleared Sep 21, 1992
MEDX ROTATIONAL GANTRY SYSTEM
K923356 · IYX
Bfi- Medical Waste Systems
Radiology · 75d
Cleared Sep 21, 1992
CLOTTRAC COAGULATION CONTROL
K923594 · JBP
Medtronic Hemotec, Inc.
Hematology · 63d
Cleared Sep 18, 1992
OXYGEN FLOW CONTROLLER
K920783 · CCN
Puritan Bennett Corp.
Anesthesiology · 211d
Cleared Sep 18, 1992
GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
K921929 · DXH
General Devices
Cardiovascular · 147d
Cleared Sep 18, 1992
NU-BREDE PACKING AND DEBRIDEMENT SPONGE
K921983 · EFQ
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 143d
Cleared Sep 18, 1992
HHI ELECTRIC CONSOLE #875-000
K922056 · HWE
H&H Instruments
Orthopedic · 137d
Cleared Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · KLI
Syva Co.
Chemistry · 155d
Cleared Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · LGC
Baxter Diagnostics, Inc.
Microbiology · 114d
Cleared Sep 18, 1992
HHI PNEUMATIC ROTARY DRILL
K922661 · HSZ
H&H Instruments
Orthopedic · 107d