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
143761–143784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1986
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702 · DTP
3M Health Care, Sarns
Cardiovascular · 92d
Cleared May 28, 1986
CAROTID BYPASS SHUNT
K860742 · DWF
Clincal Instruments Corp.
Cardiovascular · 90d
Cleared May 28, 1986
CAROTID BYPASS SHUNT WITH SAMPLING ARM
K860743 · DWF
Clincal Instruments Corp.
Cardiovascular · 90d
Cleared May 28, 1986
MEDIASTINAL AUTOTRANSFUSION SYSTEM
K860775 · DTP
Cardio Metrics, Inc.
Cardiovascular · 86d
Cleared May 28, 1986
ELASTIC LENS INJECTOR TM
K861085 · KYB
Staar Surgical Co.
Ophthalmic · 68d
Cleared May 28, 1986
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102 · DTR
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 28, 1986
CHEST DRAINAGE PACK, CDP-1000
K861103 · DWF
Gish Biomedical, Inc.
Cardiovascular · 65d
Cleared May 28, 1986
TORAY ANTHRON BYPASS TUBES
K861116 · DWF
Toray Industries (America), Inc.
Cardiovascular · 64d
Cleared May 28, 1986
CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR
K861177 · DTZ
Terumo Medical Corp.
Cardiovascular · 58d
Cleared May 28, 1986
ROPHAE DIAMOND KNIFE
K861491 · HNN
Rophae Lens Co., Inc.
Ophthalmic · 36d
Cleared May 28, 1986
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES
K861545 · HMX
Rophae Lens Co., Inc.
Ophthalmic · 34d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared May 28, 1986
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · KRK
Shiley, Inc.
Cardiovascular · 29d
Cleared May 28, 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · HNN
Storz Instrument Co.
Ophthalmic · 22d
Cleared May 27, 1986
ASSERT EO BIOLOGICAL TEST PACK
K854631 · FRC
Surgicot, Inc.
General Hospital · 190d
Cleared May 27, 1986
CONVEX PROBE, PVE-382M
K860281 · ITX
Toshiba Medical Systems
Radiology · 119d
Cleared May 27, 1986
DIASONICS 3.5 GWA 30MM PROBE
K860361 · ITX
Diasonics, Inc.
Radiology · 117d
Cleared May 27, 1986
SOF SET, MODELS 113 AND 114
K860857 · FRN
Pacesetter Systems
General Hospital · 81d
Cleared May 27, 1986
R1124 & R1686 PARAFFIN
K861344 · IMC
Tri W-G, Inc.
Physical Medicine · 50d
Cleared May 27, 1986
STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA
K861496 · DWF
Shiley, Inc.
Cardiovascular · 35d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)
K861518 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F)
K861519 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)
K861520 · FPA
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)
K861521 · FPA
Jufrey Multimed Corp.
General Hospital · 34d